(155 days)
The Skin Care system is intended for aesthetic anplications and for selective treatments required by medical dermatology specialties.
The skin care system and optional Hand pieces with 420 - 1050 nm wavelengths, with and without contact cooling, is indicated for, but not limited to:
- Hair removal and Permanent Hair Reduction in all skin types (1-VI) to the Fitzpatrick scale
- Recommended wavelengths in the range of 670-1050 nm, 755-950 nm or 580-1050 nm
- Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale
- Recommended wavelength in the range of 515-950 nm
- Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale
- Recommended wavelength in the range of 420-950 nm
- Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (1-VI) to the Fitzpatrick scale
- Recommended wavelength in the range of 560-950 nm
Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Not Found
I am sorry, but the provided text from the FDA 510(k) K152736 document for the "Skin Care" device does not contain the specific information required to answer your request.
The document is primarily a substantial equivalence determination letter, outlining the device's classification, regulatory requirements, and indications for use. It lacks details about:
- Acceptance criteria for device performance.
- Specific studies proving the device meets acceptance criteria.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for any testing.
- Training set information.
Instead, it refers to the device being substantially equivalent to legally marketed predicate devices, which means its safety and effectiveness are deemed similar to devices already on the market, rather than requiring new, detailed performance studies for this particular 510(k) submission to establish new benchmarks.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.