308nm Excimer System

FDA 510(k) K192642 · Chongqing Peninsula Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK192642

Submission

Device name
308nm Excimer System
Applicant
Chongqing Peninsula Medical Technology Co., Ltd.
Chongqing, CN
Received
September 24, 2019
Decision date
May 13, 2020
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 (K192642) received a 510(k) decision of Substantially Equivalent on May 13, 2020, 232 days after the submission was received.

What is the product code of K192642?

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