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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-12-15 under 510(k) 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. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K202827.

When did 308nm Excimer UV-light Skin Therapy System receive FDA 510(k) clearance?

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

Who is the listed applicant for 308nm Excimer UV-light Skin Therapy System?

The FDA 510(k) record lists Shenzhen Gsd Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Shenzhen Gsd Tech Co., Ltd. as applicant

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Related Devices (Code: FTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.

Official Source

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