# K152736: Skin Care

- Pathway: 510(k) (Traditional)
- Applicant: C.I.S, Ltd.
- Decided: Feb 25, 2016 after 155 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Skin Care system is intended for aesthetic and cosmetic applications 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 (I-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.

Source page: https://510kreport.com/device/K152736
Methodology: https://510kreport.com/methodology