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510(k) K213025

Laser hair growth helmet by Kam Yuen Plastic Products , Ltd. — Product Code OAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2022
Date Received
September 21, 2021
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 Kam Yuen Plastic Products , Ltd.

  • K230107 — Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 (April 5, 2023)
  • K213027 — Laser Hair Growth Comb (May 26, 2022)
  • K212907 — Aimanfun Lumea Comfort, A-2789/A-3588 (December 2, 2021)
  • K190820 — Aimanfun Lumea Comfort (October 2, 2019)

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