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510(k) K253669

TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) by Shenzhen Kaiyan Medical Equipment Co., Ltd. — Product Code OAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2026
Date Received
November 21, 2025
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

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