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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 K020973
Device Name EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO
Applicant
Surgilight, Inc.
12001 Science Dr.
Suite 140
Orlando,  FL  32826
Applicant Contact TIMOTHY SHEA
Correspondent
Surgilight, Inc.
12001 Science Dr.
Suite 140
Orlando,  FL  32826
Correspondent Contact TIMOTHY SHEA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/26/2002
Decision Date 03/29/2002
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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