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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 K924647
Device Name DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST
Applicant
Derma-Lase Co.
3 Main St.
Hopkinton,  MA  01748
Applicant Contact MICHAEL L BARRETTI
Correspondent
Derma-Lase Co.
3 Main St.
Hopkinton,  MA  01748
Correspondent Contact MICHAEL L BARRETTI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/14/1992
Decision Date 06/04/1993
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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