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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K211038
Device Name Biophotas Celluma RESTORE
Applicant
Biophotas, Inc.
1000 E. Howell Ave., Suite A
Anaheim,  CA  92805
Applicant Contact Patrick Johnson
Correspondent
Biophotas, Inc.
1000 E. Howell Ave., Suite A
Anaheim,  CA  92805
Correspondent Contact Patrick Johnson
Regulation Number890.5500
Classification Product Code
OAP  
Date Received04/07/2021
Decision Date 06/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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