WARNING LETTER

Skin Sheek MARCS-CMS 612682 — January 28, 2022

Product:: Medical Devices

Recipient:: Recipient Name

Meredith Dodini Hult; Recipient Title

President; Skin Sheek; 4431 W. Spruce Court
Highland, UT 84003
United States; service@skinsheek.com; meredithhult@gmail.com

Issuing Office:: Center for Devices and Radiological Health; United States

WARNING LETTER

January 28, 2022

Re: CLEAR, ERASE, LIFT, and SILK
Refer to CMS 612682

Dear Ms. Hult:

The United States Food and Drug Administration (FDA) has learned that your firm is marketing the CLEAR, ERASE, LIFT, and SILK in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under section 201(h) of the Act, 21 U.S.C. § 321(h), the CLEAR, ERASE, LIFT, and SILK 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.

CLEAR

FDA has reviewed your firm’s website (www.skinsheek.com)¹ and determined that the CLEAR is 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 the devices as described and marketed. The CLEAR is 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).

Our review of your firm’s website indicated that your firm is distributing the CLEAR as a “Needle-type epilator.” Devices classified under 21 CFR 878.5350 (Needle-type epilator) are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9. Generic devices of this type are only “intended to destroy the dermal papilla of a hair.” Your firm is marketing the CLEAR for different intended uses from the intended use of legally marketed devices classified under 21 CFR 878.5350. For example, your firm’s website contains a section titled “Treatable Skin Irregularities with CLEAR by Skin Sheek” that lists:

o “Telangiectasia (capillaries)”
o “Clogged Pores”
o “Skin Tags”
o “Fibromas”
o “Acne”
o “Black / White heads”
o “Sun Spots”
o “Sebaceous Hyperplasia”
o “Rosacea”
o “Cholesterol Deposits”
o “Milia”
o “Cherry Angiomas”
o “Seborrheic Keratosis”
o “Warts”

Because there is evidence that the CLEAR device is intended for different uses from those of legally marketed devices classified under 21 C.F.R. § 878.5350, it exceeds the limitations described in 21 C.F.R. § 878.9(a) and is not exempt from premarket notification.

ERASE

FDA has reviewed your firm’s website (www.skinsheek.com) and determined that the ERASE is 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 the devices as described and marketed. The ERASE is 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).

Upon review of your website, the ERASE appears to be a device classified under 21 CFR 878.4400 (Electrosurgical cutting and coagulation device and accessories). Devices classified under 21 CFR 878.4400 are not exempt from the premarket notification requirements under section 510(k) of the Act, 21 U.S.C. § 360(k).

Generic devices of this type are “intended to remove tissue and control bleeding by use of high-frequency electrical current.” Your website states that the ERASE’s mechanism of action is “Microneedles penetrate inside of the skin, and deliver RF (radio frequency) energy deep into the dermis.” Your website states that “[t]he combination of microneedles and radio frequency heats the underlying layers, causing constriction and tightening of the skin, as well as the stimulation of collagen and elastin production.” In addition, your firm’s website contains a section titled “What does Erase by Skin Sheek Treat?” that lists:

o “Acne & pore size reduction”
o “Deep acne scars”
o “Atrophic scars”
o “Burn & operation scars”
o “Skin tightening and brightening”
o “Stretch marks”
o “Effective in scar treatment”
o “Fine lines & wrinkles”
o “Cellulite”
o “Skin texture issues”
o “Pigmentation”
o “Safely treat all skin types, including tanned skin”

Your website also includes the statement that the “’Erase’ by Skin SheekTM is classified as a class 2 device by the FDA and is in compliance with applicable FDA regulatory requirements.”

LIFT

FDA has reviewed your firm’s website (www.skinsheek.com) and determined that the LIFT is 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 the devices as described and marketed. The LIFT is 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).

Upon review of your website, the LIFT appears to be a device classified under 21 CFR 878.4590 (Focused ultrasound stimulator system for aesthetic use). Devices classified under 21 CFR 878.4590 are not exempt from the premarket notification requirements under section 510(k) of the Act, 21 U.S.C. § 360(k).

Generic devices of this type use “focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption” and are intended for “noninvasive aesthetic use.” Your website states that the LIFT’s mechanism of action is “High Intensity Focused Ultrasound (HIFU)” that “directly delivers heat energy to skin and subcutaneous tissue.” In addition, your website contains a section titled “Benefits of using the Skin Sheek Lift” that lists:

o “Lifts & Tightens Cheeks”
o “Improve the Jawline”
o “Uplift Brows”
o “Turkey Neck”
o “Tighten Forehead”
o “Stubborn Fatty Area’s”
o “Buttocks”
o “Improve Skin Elasticity & Facial Contour”
o “Reduce Marionette Lines”
o “Fine Lines & Wrinkles”
o “Improve Skin Texture”
o “Cellulite”
o “Thighs”

Your website also includes the statement that “HIFU is the only non-invasive treatment cleared by the FDA to actually lift skin.”

SILK

FDA has reviewed your firm’s website (www.skinsheek.com) and determined that the SILK is 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 the devices as described and marketed. The SILK is 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).

Upon review of your website, the SILK appears to be a device classified under 21 CFR 878.4810(a)(1) and (b)(1) (Laser surgical instrument for use in general and plastic surgery and in dermatology). Devices classified under 21 CFR 878.4810(a)(1) are not exempt from the premarket notification requirements under section 510(k) of the Act, 21 U.S.C. § 360(k).

Generic devices of this type are “laser device[s] intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.” Your firm’s website states that “[t]he ‘SILK 810 nm Diode Laser by Skin Sheek makes permanent hair removal affordable for your clients.”

On February 20, 2020, FDA sent you an “It Has Come to Our Attention” letter, requesting that you provide the FDA with either clearance or approval submission number(s) for the CLEAR, ERASE, LIFT, and SILK devices. We did not receive your firm’s response and contacted you via telephone on November 12, 2020, making you aware of the requirements to legally market these devices and requesting that you provide FDA with either clearance or approval submission number(s) for the CLEAR, ERASE, LIFT, and SILK devices. During that phone call, you indicated your company does not have 510(k) clearance for the CLEAR, ERASE, or LIFT, but the company does have clearance for the SILK. On November 12, 2020, we also contacted you via email to reiterate our requests to remove claims for the CLEAR until 510(k) clearance is obtained; remove marketing for the ERASE until 510(k) clearance is obtained; remove marketing for the LIFT until 510(k) clearance is obtained or evidence is provided that 510(k) clearance is not required; and provide FDA with either a clearance or an approval submission number for the SILK. Since we did not receive a response, we attempted to follow up with you via telephone and email on November 16, 2020; however, we were unable to reach you and no responses to telephone or email messages were received. We made additional attempts to follow up with you on November 23, 2020, December 7, 2020, and December 8, 2020; however, we were again unable to reach you and no responses to telephone or email messages were received. Upon review of our records on 12/17/2021, we did not identify premarket submissions for the CLEAR, ERASE, LIFT, or SILK.

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). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that Skin Sheek cease any activities that result in the misbranding or adulteration of the CLEAR, ERASE, LIFT, and SILK devices, such as the commercial distribution of the device for the uses discussed above.

Your firm should take prompt action to address any violations identified in this letter. Failure to promptly and 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.

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) 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 by email to: CDRHWarningLetterResponses@fda.hhs.gov or by mail to:

Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993

Refer to the identification number CPT1901700 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Neil Ogden at 301-796-6397.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.

Sincerely yours,
/S/

Binita S. Ashar, MD, MBA, FACS
Director
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

_________________________

1 Last accessed 12/17/2021.