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510(k) K192642

308nm Excimer System by Chongqing Peninsula Medical Technology Co., Ltd. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2020
Date Received
September 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type

Other clearances by Chongqing Peninsula Medical Technology Co., Ltd.

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  • K172273 — 308nm Excimer System (July 30, 2018)
  • K171835 — Irradiation Aesthetic Device (January 30, 2018)

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