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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 K121471
Device Name LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
Original Applicant
LIGHTSCALPEL LLC
16932 wood-red rd ne ste 201
woodinville,  WA  98072
Original Contact gerald s palecki
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/18/2012
Decision Date 07/10/2012
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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