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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 K983524
Device Name LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
Applicant
Lares Research, Inc.
295 Lockheed Ave.
Chico,  CA  95973
Applicant Contact THOMAS H LOUISELL
Correspondent
Lares Research, Inc.
295 Lockheed Ave.
Chico,  CA  95973
Correspondent Contact THOMAS H LOUISELL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/08/1998
Decision Date 04/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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