Manufacturer
Hebei Keylaser Sci-Tech Co.,LtdQ-Switched Nd:Yag laser (K690)
Hebei Keylaser Sci-Tech Co.,Ltd
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252515
- Device name
- Q-Switched Nd:Yag laser (K690)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-08-11
- Decision date
- 2025-11-06
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatmentHair removalSkin resurfacingAcne treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
1Nd: YAG Laser Therapy Systems HM-YL900
K252515 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252515 as a predicate