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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 K222685
Device Name NIRA Model 2
Applicant
Dermal Photonics Corp
153 Andover St., Suite 111
Danvers,  MA  01923
Applicant Contact Felix Feldchtein
Correspondent
Dermal Photonics Corp
153 Andover St., Suite 111
Danvers,  MA  01923
Correspondent Contact Felix Feldchtein
Regulation Number878.4810
Classification Product Code
OHS  
Date Received09/06/2022
Decision Date 02/08/2023
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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