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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 K980160
Device Name EPILASER I UPGRADE KIT
Applicant
Palomar Medical Products, Inc.
45 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact ANTHONY FIORILLO
Correspondent
Palomar Medical Products, Inc.
45 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact ANTHONY FIORILLO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/16/1998
Decision Date 03/10/1998
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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