Manufacturer
Beijing Nubway S&T Co., Ltd.Q Switched Nd:YAG Laser machine (QNHF-01)
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
- K242943
- Device name
- Q Switched Nd:YAG Laser machine (QNHF-01)
- Company
- Beijing Nubway S&T Co., Ltd.
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-09-25
- Decision date
- 2025-03-03
- 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 (QNHF-01) 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 machine (QNHF-01) 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
Q Switched Nd: YAG Laser machine (QNHF-01) is laser system which delivers laser at a wavelength 1064nm or 532nm. 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.
Summary parsed at:2026-06-01 05:21:27 UTC
Predicate devices
1Q-Switched Nd:YAG Laser Therapy Systems
K242943 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 K242943 as a predicate
