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FDA 510(k)

308nm Excimer UV-light Skin Therapy System

K-Number: K202827 · 2020-12-15

ApplicantShenzhen Gsd Tech Co., Ltd.
Decision Date2020-12-15
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

308nm Excimer UV-light Skin Therapy System is a medical device manufactured by Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-12-15 under approval number K202827. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 308nm Excimer UV-light Skin Therapy System?

308nm Excimer UV-light Skin Therapy System is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K202827.

When was 308nm Excimer UV-light Skin Therapy System approved by the FDA?

308nm Excimer UV-light Skin Therapy System received FDA 510(k) clearance on 2020-12-15, under approval number K202827.

What company makes 308nm Excimer UV-light Skin Therapy System?

308nm Excimer UV-light Skin Therapy System is manufactured by Shenzhen Gsd Tech Co., Ltd..

What is the FDA product code for 308nm Excimer UV-light Skin Therapy System?

The FDA product code for 308nm Excimer UV-light Skin Therapy System is FTC.

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Related PubMed Literature

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Other Devices by Shenzhen Gsd Tech Co., Ltd.

K180383Light based hair removal device K191518CO2 Laser System K213225Diode Laser System GP900A8, Diode Laser System GP900Q8 K230060Light Based Hair Removal Device GP592

Related Devices (Code: FTC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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