Hebei Keylaser Sci-Tech Co.,Ltd
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Q-Switch Nd:Yag laser is intended for use in removal of dark ink (black, blue and brown) tattoo, removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma, removal or lightening of unwanted hair with or without adjuvant preparation, skin resurfacing procedures for the treatment of acne scars and wrinkles.
The Q-Switch Nd:Yag laser is intended for use in removal of dark ink (black, blue and brown) tattoo, removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma, removal or lightening of unwanted hair with or without adjuvant preparation, skin resurfacing procedures for the treatment of acne scars and wrinkles.
Q-Switched Nd:Yag laser consists of a main engine, controller, power control switch, optical system and power input panel. A multifunctional microcomputer can control and adjust the size of the laser spot, making it suitable for treating diseases in different parts of the body. Parameters such as the laser energy required for the treatment can be set by the user appropriately.
Summary parsed at:2026-06-01 05:23:57 UTC
Nd: YAG Laser Therapy Systems HM-YL900
K252515 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K252515 as a predicate
