Manufacturer
Sanhe Lefis Electronics Co., Ltd.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
Product code
GEX
21 CFR 878.4810
Cited as predicate
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
Predicate devices
2CuRAS Nd:YAG Laser
Q Switched Nd: YAG Laser machine
K252319 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252319 as a predicate
