308nm Excimer System

FDA 510(k) K172273 · Chongqing Peninsula Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK172273

Submission

Device name
308nm Excimer System
Applicant
Chongqing Peninsula Medical Technology Co., Ltd.
Chongqing, CN
Received
July 28, 2017
Decision date
July 30, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FTC – Light, Ultraviolet, Dermatological
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4630
Specialty
General, Plastic Surgery

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Questions and answers

When was 308nm Excimer System cleared by the FDA?

308nm Excimer System (K172273) received a 510(k) decision of Substantially Equivalent on July 30, 2018, 367 days after the submission was received.

What is the product code of K172273?

The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.