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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K171323
Device Name BIOPHOTAS CELLUMA3
Applicant
Biophotas, Inc.
1000 E. Howell Ave., Suite A
Anaheim,  CA  92805
Applicant Contact PATRICK JOHNSON
Correspondent
Ismart Consulting US
1004 W. Tuscany View Rd. #205
Midvale,  UT  84047
Correspondent Contact STEVEN BAKER
Regulation Number878.4810
Classification Product Code
OHS  
Date Received05/05/2017
Decision Date 09/01/2017
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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