Q-Switched Nd:YAG Laser (SHE-LSP101-1)

Beijing Sano Laser S&T Development Co.,Ltd

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

2

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0

Device details

FDA 510(k) registration fields

K number
K250936
Device name
Q-Switched Nd:YAG Laser (SHE-LSP101-1)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-03-28
Decision date
2025-06-12
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentVascular treatmentSurgical cutting
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The Q-Switched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for General Dermatology, Dermatologic and General Surgical Procedures as follows:

1064nm:
-Tattoo removal dark ink: blue and black
-Treatment of Benign Pigmented Lesions Nevus of ota

532nm:
-Tattoo removal Light ink: red, sky blue and green.
-Treatment of benign vascular lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.
-Treatment of benign pigmented lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Intended Use

The Q-Switched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for General Dermatology, Dermatologic and General Surgical Procedures as follows: 1064nm: -Tattoo removal dark ink: blue and black -Treatment of Benign Pigmented Lesions Nevus of ota 532nm: -Tattoo removal Light ink: red, sky blue and green. -Treatment of benign vascular lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of benign pigmented lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Device Description

Q-Switched Nd:YAG Laser is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel. Machine System Q-Switched Nd:YAG Laser consists of machine main body (including Laser Device, Transmission and Target Indicating Device, Laser Power Supply and Control System, Safety Protection System, Cooling System, Power Supply System, Control System), 7-Joint Laser Arm, Vari-Focusing Handpiece, Foot Switch, Laser Protective Glasses, Power Cable, Support Bar (A Group of Support Bar and 2 Support Clamps), Casters and Attached Machine Accessories. The machine shell is ABS shell, its accessories are aluminum alloy parts. Performance Laser Peak Wavelength 1064nm & 532nm, ±5nm.

Summary parsed at:2026-06-01 05:22:41 UTC

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