Inspections, Compliance, Enforcement, and Criminal Investigations
Quanta Aesthetic Lasers USA, LLC 7/16/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|9200 Corporate Boulevard|
Rockville, MD 20850
June 16, 2012
Thomas G. Perito
Chief Operating Officer
Quanta Aesthetic Lasers USA, LLC
14 Inverness Drive East, Suite B104
Englewood, CO 80112
Re: Quanta System Q-Plus T
Refer to CPT1200001 when replying to this letter.
Dear Mr. Perito:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Quanta System Q-Plus T in the United States. This product is a device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because it is 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. As explained below, this device is being marketed without required clearance or approval in violation of the Act.
Your firm obtained clearance of the Quanta System Q-Plus T (K073549) under section 510(k) of the Act, 21 U.S.C. § 360(k), for the following indications:
Nd:YAG (1064nm) and (532nm)
The Q-Plus T Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
The Q-Plus T Q-Switched laser is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are
- Benign Naevi such as:
- Naevus of Ota
- Naevus of Ito
- Epidermal Naevi
- Congenital Naevi
- Beckers Naevi
- Blue Nevus
- Naevus Spillus
- Mongolian Spot
The Office of Compliance, in FDA’s Center for Devices and Radiological Health, recently reviewed your firm’s website, www.quantausa.com, and found the following claims for the Quanta System Q-Plus T:
“Q Plus Series
The Short and Long pulsed additional modules effectively perform hair removal, treatment of vascular lesions, skin rejuvenation and tightening. These modules are composed by Nd:YAG (at 1064 and 1320 nm), Alexandrite (at 755 nm) and IPL. This combination provides the best benefit/cost ratio available on the market.”
“Options . . . Twain 1320
Optional for any ND:Yag of this series is the 1320 nm wavelength. Thanks to its higher absorption by water and great penetration into the dermis, it is very effective for collagen remodeling through the fibroblasts stimulation. It consequently enhances the applications of the system on:
- Fine wrinkles
- Enlarged pores
- Acne scars
- Keloids, smoothness and skin lifting
- Skin rejuvenation”
“Treatment with the 400 nm IPL handpiece reduces the sebaceous secretion and activating the porphyrins, leads to the formation of oxygen which causes the death of the microorganism causing acne.”
Promotion of the Quanta System Q-Plus T for skin rejuvenation, skin lifting, skin tightening/smoothness, acne treatments, anti-aging, firming, and treatment of scars and keloids represents a major change in the intended use of the device, which could affect its safety and effectiveness. Therefore, the Quanta Q-Plus T Laser 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device 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 device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and 21 CFR 807.81(a)(3)(ii). . The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
For a device requiring premarket approval, the notification required by section 510(k) of the Act 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/cdrh/devadvice/3122.html
The Office of Compliance requests that Quanta Aesthetic Lasers USA, LLC, immediately cease the dissemination of promotional materials for the Quanta System Q-Plus T the same as or similar to those described above.
FDA has also learned that your firm modified treatment parameters for the Quanta System Q-Plus T with the addition of 1320 nm, 755 nm, 2940 nm, radio frequency, and intense light-pulsed hand pieces. This represents a significant technological change that could affect the safety and effectiveness of the device. Therefore, the GenesisPlus is further misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i).
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of 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 correct 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 (including any systemic corrective actions) 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 all violations included in this Warning Letter.
Your firm’s response should be sent to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Operations Branch
10903 New Hampshire Avenue
Silver Spring, MD 20993
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. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the product into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and