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510(k) K141567

IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM by Apira Science, Inc. — Product Code OAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2014
Date Received
June 12, 2014
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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