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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 K021227
Device Name SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
Applicant
Zap Lasers, LLC
2643 Pleasant Hill Rd.
Pleasant Hill,  CA  94523
Applicant Contact JAY GOBLE
Correspondent
Zap Lasers, LLC
2643 Pleasant Hill Rd.
Pleasant Hill,  CA  94523
Correspondent Contact JAY GOBLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/18/2002
Decision Date 06/26/2002
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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