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510(k) K192552

Irradiation Cosmetic Device by Chongqing Peninsula Medical Technology Co., Ltd. — Product Code OAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2020
Date Received
September 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Comb, Hair
Device Class
Class II
Regulation Number
890.5500
Review Panel
SU
Submission Type

Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v

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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