Q-Switched Nd:YAG Laser Therapy Systems
Beijing Sincoheren Science and Technology Development Co.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K163123
- Device name
- Q-Switched Nd:YAG Laser Therapy Systems
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-11-08
- Decision date
- 2017-02-02
- Submission type
- Traditional
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The Q-Switched Nd:YAG Laser Therapy System (1064nm or 532nm) 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.
Intended Use
The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) 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 Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system. The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy from particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body. The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.
Summary parsed at:2026-06-01 05:59:12 UTC
Predicate devices
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Not ingested
K163123 references 1 predicate/reference device
Cited as predicate
2Q Switched Nd: YAG Laser machine
Q Switched Nd:YAG Laser machine (QNHF-01)
2 submissions cite K163123 as a predicate
