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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
Applicant
Lightscalpel, LLC
16932 Wood-Red Rd. NE Suite 201
Woodinville,  WA  98072
Applicant Contact GERALD S PALECKI
Correspondent
Lightscalpel, LLC
16932 Wood-Red Rd. NE Suite 201
Woodinville,  WA  98072
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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