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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(K) Number K122020
Models PHOTON, PHOTON PLUS
Device Name PHOTON PHOTON PLUS
Applicant
ZOLAR TECHNOLOGY & MFG. CO. INC.
55 northern blvd
suite 200
great neck,  NY  11021
Contact susan d goldstein-falk
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/10/2012
Decision Date 06/05/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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