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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fat Reducing Low Level Laser
510(k) Number K232977
Device Name Biophotas Celluma CONTOUR
Applicant
Biophotas, Inc.
15501 Red Hill Ave., #200
Tustin,  CA  92780
Applicant Contact Patrick Johnson
Correspondent
Biophotas, Inc.
15501 Red Hill Ave., #200
Tustin,  CA  92780
Correspondent Contact Patrick Johnson
Regulation Number878.5400
Classification Product Code
OLI  
Subsequent Product Codes
ILY   OHS  
Date Received09/21/2023
Decision Date 11/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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