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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 K150336
Device Name Photonica Professional
Applicant
Ward Photonics LLC
1980 N Atlantic Avenue
cocoa beach,  FL  32931
Applicant Contact terry ward
Correspondent
THIRD PARTY REVIEW GROUP, LLC
45 ROCKEFELLER PLAZA
SUITE 2000
new york,  NY  10111
Correspondent Contact dave yungvirt
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/10/2015
Decision Date 02/24/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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