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Q Switched Nd:YAG Laser machine (QNHF-01)

Beijing Nubway S&T Co., Ltd.

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

Product code GEX· 21 CFR 878.4810

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Company

Beijing Nubway S&T Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

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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

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