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510(k) K253231

Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) by Hubei Yjt Technology Co.,Ltd — Product Code OAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2026
Date Received
September 29, 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

Other clearances by Hubei Yjt Technology Co.,Ltd

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