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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 K141658
Device Name LIGHT SCALPEL
Applicant
LIGHT SCALPEL LLC
16932 WOODINIVILLE-REDMOND RD NE, SUITE 107
WOODINIVILLE,  WA  98072
Applicant Contact DAVID WALTERS
Correspondent
LIGHT SCALPEL LLC
16932 WOODINIVILLE-REDMOND RD NE, SUITE 107
WOODINIVILLE,  WA  98072
Correspondent Contact DAVID WALTERS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/20/2014
Decision Date 10/22/2014
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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