# K172908: Q-Switched Nd:YAG Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Ami, Inc.
- Decided: Dec 7, 2017 after 73 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 Q-MASTER Q-Switched Nd:YAG Laser System is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology. 1064nm wavelength in Q-switched mode: - Removal of dark ink (black, blue and brown) tattoos - Treatment of nevus of Ota - Treatment of common nevus - Removal or lightening of unwanted hair - Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064nm wavelength in non Q-switched mode: - Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9 and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin - Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650nm with the optional 585nm and 650nm dye hand-piece): - Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos - Treatment of benign vascular lesions including, but not limited to: - port wine birthmarks - telangiectasias - spider angioma - cherry angioma - spider nevus - Treatment of benign pigmented lesions including, but not limited to: - café-au-lait birthmarks - solar lentigines - senile lentigines - Becker’s nevus - freckles - common nevus - nevus spilus - Treatment of seborrheic keratosis - Treatment of post inflammatory hyperpigmentation - Skin resurfacing procedures for the treatment of acne scars and wrinkles

Source page: https://510kreport.com/device/K172908
Methodology: https://510kreport.com/methodology