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510(k) K230336

CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) by Light Tree Ventures Europe B.V. — Product Code OAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2023
Date Received
February 7, 2023
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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Other clearances for product code OAP

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  • K252414 — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) (October 30, 2025)
  • K252325 — Hair Growth Laser Cap (October 22, 2025)
  • K251017 — CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (June 17, 2025)
  • K250467 — Red Light Hair Growth Cap (LP-RJVGRW-BLK) (June 5, 2025)
  • K250308 — Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, K (April 29, 2025)
  • K242747 — FAQ™ (302) (December 11, 2024)
  • K242619 — GroWell BT Hair Growth System (GW10042) (December 2, 2024)
  • K242363 — HIGHERDOSE Red Light Hat (HG-120K) (November 20, 2024)