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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 K081214
Device Name STYLA MICROLASER AND STYLAORTHO
Applicant
Zap Lasers, LLC
2621 Pleasant Hill Rd.
Pleasant Hill,  CA  94523
Applicant Contact JAY GOBLE
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131 -1230
Correspondent Contact MORTEN CHRISTENSEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/30/2008
Decision Date 05/14/2008
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
Predetermined Change
Control Plan Authorized		 No
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