Q-Switched Nd: YAG Laser machine (LFS-C13U)

Sanhe Lefis Electronics 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
K252319
Device name
Q-Switched Nd: YAG Laser machine (LFS-C13U)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-07-25
Decision date
2025-10-20
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 machine 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 as follows:

1064nm:
-Tattoo Removal
Dark ink: blue and black.
-Treatment of Benign Pigmented Lesions
Nevus of ota.

532nm:
-Tattoo Removal
Light ink: red, Light ink: 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.

Environment of Use: Medical institutions, including hospitals, clinics, etc.

Intended Use

The Q-Switched Nd: YAG Laser machine 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 as follows: 1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532nm: -Tattoo Removal Light ink: red, Light ink: 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

The Q-Switched Nd: YAG Laser machine is a laser system which delivers light at a wavelength 1064nm or 532nm. The device comprises a main unit, light guide arm and footswitch. The working principle of Q-Switched Nd: YAG Laser machine is that neodymium ions in neodymium doped yttrium aluminum garnet crystals are excited by the energy provided by the pump source and release photons. These photons are repeatedly reflected and stimulated to emit in the optical resonant cavity of the crystal, ultimately producing a specific wavelength (mainly 1064nm) and high energy density laser beam. It can also be converted from a 1064nm wavelength laser beam to a 532nm laser beam through frequency doubling technology; Then, it is effectively transmitted to the treatment site through the beam transmission device and plays a therapeutic role through the photothermal effect.

Summary parsed at:2026-06-01 05:23:41 UTC

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