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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
Device Name PHOTON PHOTON PLUS
Applicant
ZOLAR TECHNOLOGY & MFG. CO. INC.
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
ZOLAR TECHNOLOGY & MFG. CO. INC.
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/10/2012
Decision Date 06/05/2013
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
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