- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Medical Devices
Recipient NameAnthony “Tony” E. Picciano
- Neurotris, Inc. dba A1 Engineering
30 Mauchly Ste A
Irvine, CA 92618
- Issuing Office:
- Center for Devices and Radiological Health
CMS # 659244
October 27, 2023
Dear Mr. Picciano:
During an inspection of your firm, Neurotris, Inc. (Neurotris or NeurotriS or “the firm”), located in Irvine, CA, on April 4, 2023, through April 25, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer and distributor of Class II Powered Muscle Stimulator devices such as the Neurotris SX or SVX Series Facial Body Systems, which may also be referred to as the Neurotris Body System. These medical devices include, but are not limited to, the SX2500 (Picowave), SX3800, SX4500, SVX650, PICO Toner, and accessories such as electrodes, conductive gels, and spray. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
We received your response, dated May 6, 2023, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address the response below, in relation to each of the noted violations, and any additional responses will be reviewed as part of your warning letter response.
Misbranded and/or Unapproved Device Violations
Our inspection and review of the available information, including the firm’s website, www.neurotris.com, revealed that the Neurotris SX2500 (Picowave), SX3800, SX4500, SVX650, PICO Toner, and accessories such as electrodes (ANMA lift, Probes, Silver Facial Sculpting Gloves, Facial Pads), conductive gels, and spray, are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for these devices as described and marketed. The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency (21 CFR 807.81(b)(1)).
You currently have a clearance for the Body System (models SX101 and 0S2911) dated February 26, 2019, as a prescription device, under K182440. The Body System was cleared as a Powered Muscle Stimulator for muscle conditioning under 21 CFR 890.5850 product code NGX for the following indications:
“The Body System is intended for muscle conditioning to stimulate healthy muscles. The Body System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.”
Based on the evidence reviewed at the April 2023 inspection and other available information, including statements on your firm’s website [https://www.neurotris.com] and social media [Facebook], last reviewed on August 13, 2023, as described below, the devices cited in this letter have intended uses that exceed or otherwise differ from your 510(k) clearance for the Body System device and the classification codified at 21 CFR 890.5850, such that premarket notification is required prior to introduction or delivery for introduction of these devices into interstate commerce for commercial distribution per 21 CFR 807.81(a). Additionally, your devices appear to have different technological characteristics than the original 510(k) cleared device, including, among others, differences in power sources, number of channels, and device accessories, which could significantly affect the safety or effectiveness of the device. Further, the following changes represent significant changes or modifications outside the scope of the K182440 clearance in the design, components, method of manufacture, or intended use of your cleared device, which could also significantly affect its safety and effectiveness.
Neurotris SX2500 (Picowave), SX3800, SX4500, SVX650, and PICO Toner:
The original Body System devices (models SX101 and 0S2911) were cleared under K182440. A review of your website and manuals for your current Neurotris devices, the SX2500 (Picowave), SX3800, SX4500, SVX650, and PICO Toner show that these new devices have different technical characteristics than those of the SX101 and OS2911. These differences include variations between the number of channels compared to the cleared devices. In addition, models SX101 and OS2911 are mains powered but the PICO Toner II is battery powered. It also appears that the circuitry of the devices may be different from the cleared device. All of these changes in the technical characteristics create potential differences in the electrical safety and electromagnetic compatibility of your devices compared to the tested and cleared device, which may lead to risks associated with electric shock, excessive temperatures, burns, and interference. Such changes and modifications could significantly affect the safety and effectiveness of these devices. Therefore, such technical differences would require a new 510(k).
Additionally, there are significant differences between how your originally cleared devices and the new devices are intended to be used, according to the labeling. As described in “Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff” (fda.gov), changes to labeling, including the Indications for Use, require review in a new 510(k). The guidance notes that the decision to submit a new 510(k) may apply not only to changes to the indications for use statement of the labeling, but also to changes to other sections of the labeling, such as the directions for use of the device. The original devices were cleared as Powered Muscle Stimulators for muscle conditioning under 21 CFR 890.5850 product code NGX. The cleared indication for use states, “The Body System is intended for muscle conditioning to stimulate healthy muscles.” However, a review of your Neurotris SX2500 (Picowave), SX3800, SX4500, SVX650, and PICO Toner manuals show that the intended use of these devices is “to stimulate nerves and muscles, causing muscle contraction for esthetic beautification.” The stimulation of nerves for aesthetic purposes is a significant change in how and where the device is intended to be used from your cleared 510(k) device. Stimulation of nerves as opposed to muscles raises new questions of safety and effectiveness requiring FDA review prior to marketing. Additionally, stimulation of nerves exceeds the intended use definition of devices classified under 21 CFR 890.5850 for powered muscle stimulators.
Furthermore, there is significant risk related to the new anatomical areas of use that are promoted by your firm. The original cleared Body System manuals (models SX101 and 0S2911) have the following warnings against use on the chest, significant portions of the face, and neck:
- “Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing.”
- “Stimulation should not be applied transthoracically in that the introduction of electrical current in the heart may cause cardiac arrhythmias”
- “Stimulation should not be applied transcerebrally"
Yet, multiple statements on your firm’s website, social media, and user manuals promote the use of Neurotris SX2500 (Picowave), SX3800, SX4500, SVX650, and PICO Toner on these prohibited areas.
Examples of promotional statements from your website, social media, and manual that are beyond the clearance of your device under 21 CFR 890.5850 for Powered Muscle Stimulators include but are not limited to (refers to Neurotris website labeling unless otherwise noted):
- Auto Mode 2 BUILD (FACE LIFTING) (Manual)
- “This client is having an amazing result with NEUROTRIS Picowave Microcurrent and Rezenerate! Notice the reduction in her lines and wrinkles (especially around her mouth). Her face is smooth and lifted.” (Neurotris Facebook)
- “This is our premiere facial system. The SX3800 will allow you to treat the most challenging skin types who come into your treatment room. The power in the SX3800 is not matched in any other machine on the market. You will be able to lift, tone and tighten facial muscles for clients who have deep wrinkles and severe skin laxity.”
- “You will be able to help them to diminish the appearance of crow’s feet, the dreaded 11’s between the eyebrows, you can lift the mid-face to help reduce any sagging in the nasal labial fold, you can also lift drooping jowls and help to tighten up loose skin on the neck that can lead to the “turkey wattle.”
- “The SX3800 can also improve and reduce the appearance of cellulite on the body. The Dynamic Microcurrent technology oxygenates the skin cells by increasing blood and lymphatic flow.”
- “You will be able to lift, tone and tighten facial muscles for clients who have deep wrinkles and severe skin laxity.”
- “You can also help your clients find lift, toning and tightening in very specific areas of the face with the Infinity Probes. These are designed to help plump the lips to eliminate smokers lines around the mouth, they can be used around the eye to offer a lid lift and reduce under eye puffiness.”
- “The proprietary body channel wavelength settings on the NeurotriS SX4500 are designed to induce lipolysis in the adipose tissue in the body. That means that the NeurotriS SX-4500 can send microcurrents into the fat cells that will cause them to burst and then die, thus, fat reduction.”
- “Incorporates 2 Functional Signal Technologies: Level 1 Lipolysis, for Shrinking Fat Cells; Lever 2 Toning, for Inch Loss & Musclebuilding”
- “The Pico Toner comes standard with the highest quality Silver Toning gloves available today. You have the option to add toning probes and or facial toning pads to personalize your treatment needs. The toning gloves allows for more surface area to be treated as the probes can be used to treat fine areas. Use the Facial toning pads as a static treatment to focus on areas over the eye or nasolabial folds.”
- “The PICO Toner™ For Personal Facial & Body Toning uses one AAA battery and has a long battery life. The smart feature built in automatically shuts off the unit after the 20 minute session.”
We have reviewed your firm’s response dated May 6, 2023, regarding your PICO Toner device and determined that it is not adequate. You state that the PICO Toner “is manufactured by Prism medical and rebranded from the Micro Z mini.” We reviewed FDA’s Establishment Registration & Device Listing database, which notes premarket submission K024181 as the 510(k) clearance number for devices with the following proprietary names: Micro-ZII, Micro-Z Mini, MICRO-Z STIMULATION SYSTEM, and SaeboStim Micro. Review of the 510(k) Summary outlined within our 510(k) Premarket Notification database showed that the Prizm Medical, Inc. Micro-Z™ Stimulation System was cleared under K024181 as a Transcutaneous Electric Nerve Stimulator (TENS), Class II under 21 CFR 882.5890 and product codes IPF and GZJ. As specified in the publicly available 510(k) Summary for the Prizm Medical, Inc. Micro-Z™ Stimulation System, the device was cleared as a TENS device for symptomatic relief and management of chronic (long-term) intractable (not easily controlled) pain, and to help with the management of post-surgical and post-traumatic acute pain problems. As such, the device was not cleared for use on the face, or for aesthetic purposes. Therefore, the Prizm Medical, Inc. Micro-Z™ Stimulation System would be subject to a new premarket notification, as would the PICO Toner, for the current marketed indications, as described in Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (fda.gov), which specifically states that changes to the type of joint, organ, bone, vasculature, or tissue to which a device is applied is likely to require submission of a new 510(k).
We note that Transcutaneous Electric Nerve Simulation (TENS) units may have different intended uses and operating specifications. TENS units intended for aesthetic purposes are classified under 21 CFR 882.5890, with product code NFO, considered a Class II device type, and subject to premarket notification. Due to the significant change in intended use as well as raising new questions of safety and effectiveness (i.e., cleared K024181 nerve stimulation for pain relief under product codes GZJ versus a device for aesthetic purposes under product code NFO), a new premarket submission is required. Devices that are intended to be used on the face and for aesthetic purposes have much lower levels of stimulation output than TENS devices intended for pain relief such as that cleared under K024181. It is not clear that the device cleared under K024181 could be safely and effectively used on the face, as there are risks associated with potential stimulation of facial nerves and eye or nerve damage due to the thinner skin of the face and the more proximal facial nerves.
The original electrodes cleared for use with the Body System were self-adhesive pad applicators cleared under K970426. A review of your website and manuals shows that you are marketing additional accessories such as “Probes,” “Silver Facial Sculpting Gloves,” “Facial Pads,” and the “ANMA Lift”. These accessories appear to meet the definition of device under section 201(h) of the Act and are subject to premarket notification as they are electrodes that provide stimulation, which affects the structures of the body they contact. Cutaneous electrodes are regulated under 21 CFR 882.1320 (product code GXY). These additional accessories have different technological characteristics than those self-adhesive pad applicators cleared under K970426. Specifically, many of the currently marketed electrodes have different shapes and dimensions which can lead to a risk of non-uniform current distribution, higher current densities, and increase the risk of burns. Thus, there is potential for adverse events if the electrical response of the system and accessories has not been assessed. Furthermore, the additional accessories are composed of different materials than those cleared under K970426. This raises concerns of potential biological response because of unknown biocompatibility due to lack of assessment.
Additionally, during our review we found multiple unsubstantiated promotional statements from your website that represent differences from that of the cleared electrode device labeling. These statements include the following (refers to website labeling unless otherwise noted):
- “Purchase the ANMA Lift as an accessory to your existing SX Series NeurotriS Professional system or the Picotoner Home unit. This revolutionary dual probe fuels a highly effective facial massage tool with the technology of NeurotriS Dynamic Microcurrent to create a Lifting & Sculpting Probe for any NeurotriS series systems in the treatment room that can be used on the face and body! You can use one or two probes.”
- “This treatment has been called the “non-surgical facelift.” (Neurotris Facebook)
- “This revolutionary dual probe fuels a highly effective facial massage tool with the technology of NeurotriS Dynamic Microcurrent to create a Lifting & Sculpting Probe for any NeurotriS series systems in the treatment room. What is your favorite way to treat the neck and jawline?” (Neurotris Facebook)
Silver Facial Sculpting Gloves
- “Our Silver Facial Sculpting Gloves™ are designed to deliver the appropriate intrinsic dielectric property and promises a uniform disbursement of the Specific Frequency Signature (SFS) energy throughout the entire surface of the glove giving you Maximum Performance!”
NEW Infinity Probes Pair vs 2
- “Our NEW VERSION infinity probes are single channel probes used to treat smaller skin surface areas and for Iontophoresis. The Infinity probes are for all SX series facial machines & the Pico Toner. The tips for the single probes are interchangeable for various sizes. Includes replaceable Probe cable that is User serviceable. NEW Medical grade High polish Stainless steel tips.”
Please note that iontophoresis devices, including associated electrodes as mentioned in the last claim listed above from the website, are regulated under 21 CFR 890.5525. It does not appear that any such devices have been cleared for aesthetic purposes. Additionally, these devices have specific performance testing required prior to clearance, as described in the regulation. You do not appear to have a clearance for an iontophoresis device or associated accessories.
Gels & Spray:
We note that your firm’s website and materials collected during the inspection include references to several conductive gels and sprays such as “Conductive Gel,” “Ion Spray,” and “Stem Cell Molecule Gel” that are not cleared with the device reviewed in K182440. Electroconductive media such as conductive spray and gel are a Class II medical device under 21 CFR 882.1275, product code GYB and are not exempt from 510(k) notification.
Your firm’s response dated May 6, 2023, regarding the conductive gels and spray is not adequate. Your firm has explained that the conductive gels & spray are formulated by (b)(6) and that your firm plans to add these items to your FDA registration. However, no clearance number has been provided by your firm and these conductive gels and spray require a premarket submission. It is important to determine that the electroconductive properties of a new spray or gel are substantially equivalent to those of a predicate device and that all claims are either substantially equivalent to those previously cleared and/or supported by performance data (valid scientific evidence). Furthermore, there is a risk of adverse biological response to users if the biocompatibility safety of these sprays and gels has not been assessed.
Quality System Regulation (QSR) Violations
Our inspection also revealed that the Body System medical devices (SX or SVX devices, PICO Toner) are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures for design validation as required by 21 CFR 820.30(g).
Specifically, you had opened Corrective and Preventive Actions (CAPAs) 027 and 028 in 2021 to address issues with devices continuing to pulse with or without the start/step push buttons being activated. These CAPAs described changes to the SX-3800 and SX-4500 devices. The CAPAs stated that validations were pending but you could not provide evidence of completion of validation of the design changes.
We have reviewed your firm’s response and concluded that it is not adequate. You stated that you “promise to correct” but you did not provide any documentation of the completion of validations and assessment as effective for these CAPA design changes.
2. Failure to adequately establish and maintain procedures for corrective and preventive action as required by 21 CFR 820.100.
Specifically, you had opened CAPA 033 to address a light emitting diode (LED) light issue with your SX-4500 device and you corrected it by applying hot glue to exposed terminals. You closed the CAPA without evidence that the issue was effectively corrected. In addition, your CAPA procedure states that the Quality Manager will review customer complaints and initiate a Corrective Action Report. You stated that you (as owner) are responsible for complaint analysis, but you could not provide evidence that complaints were analyzed or trended.
We have reviewed your firm’s response and concluded that it is not adequate. You stated that you “promise to correct” but you did not provide any documentation of assessment as effective for CAPA 033 or that you perform complaint analyses per your CAPA procedure.
3. Failure to adequately establish and maintain procedures for rework as required by 21 CFR 820.90(b)(2).
Specifically, your Control of Non-Conforming Product procedure requires that rework evaluation results be recorded or attached to the Non Conformance Report (NCR) file. For NCR 050, April 2021, the start/stop button on SX-3800 device switches not performing as intended, the disposition was documented as ‘rework’. You could not provide evidence of the rework/evaluation. Serial number 2200 of the device was released and shipped in July 2021 with the NCR still open.
We have reviewed your firm’s response and concluded that it is not adequate. You stated that you “promise to correct” but you did not provide any documentation of rework for your SX-3800 device in NCR 050.
4. Failure to evaluate and select potential suppliers on their ability to meet specified requirements and define the type and extent of control to be exercised over suppliers as required by 21 CFR 820.50(a).
Specifically, your Purchasing procedure, QP-706, Rev. 9 and Supplier Evaluation procedure, QP-705, Rev. 8, do not state the extent and type of control your firm has over your suppliers such as Prizm Medical and SRC Labs. Prizm Medical is the manufacturer of the PICO Toner device and SRC Labs is a supplier of gels and sprays used with Neurotris’ devices. You stated during the inspection that you have a “verbal and handshake agreement” with both suppliers. You have not documented any evaluation of Prizm Medical and SRC Labs and you have failed to demonstrate how you used any evaluation to define the type and extent of control to be exercised over those suppliers.
We reviewed your firm’s response and conclude that it is not adequate. You stated that you “promise to correct” but you did not provide any documentation of control over your suppliers Prism Medical or SRC Labs other than to state that you “will work together” with these firms who “use a quality management system”.
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent to: Jessica Mu, Director of Compliance Branch at firstname.lastname@example.org Refer to CMS # 659244 when replying. If you have any questions about the contents of this letter, please contact: Raymond W. Brullo, Compliance Officer at 949-608-2918 or email@example.com.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
CAPT Nina Mezu-Nwaba, PharmD., MPH., MSc
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Shari J. Shambaugh
Program Division Director
Office of Medical Devices and Radiological Health Operations