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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 K884311
Device Name MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS
Applicant
Surgilase, Inc.
I-95 Corporate Park
33 Plan Way
Warwick,  RI  02866
Applicant Contact TIMOTHY J SHEA
Correspondent
Surgilase, Inc.
I-95 Corporate Park
33 Plan Way
Warwick,  RI  02866
Correspondent Contact TIMOTHY J SHEA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/13/1988
Decision Date 10/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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