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FDA 510(k)

308nm Excimer System

K-Number: K192642 · 2020-05-13

ApplicantChongqing Peninsula Medical Technology Co., Ltd.
Decision Date2020-05-13
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

308nm Excimer System is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Peninsula Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K192642. 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 System?

308nm Excimer System is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Chongqing Peninsula Medical Technology Co., Ltd.. The 510(k) number is K192642.

When did 308nm Excimer System receive FDA 510(k) clearance?

308nm Excimer System received FDA 510(k) clearance on 2020-05-13, under 510(k) number K192642.

Who is the listed applicant for 308nm Excimer System?

The FDA 510(k) record lists Chongqing Peninsula Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 308nm Excimer System?

The FDA product code for 308nm Excimer System is FTC.

Other records listing Chongqing Peninsula Medical Technology Co., Ltd. as applicant

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.

K192552Irradiation Cosmetic DeviceK172273308nm Excimer SystemK171835Irradiation Aesthetic Device

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

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