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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 K860083
Device Name DERMASCAN LASER SURGICAL HANDPIECE
Applicant
Medical Laser Research & Development Corp.
46 Clark St.
Malden,  MA  02148
Applicant Contact DONNA BOURGELAIS
Correspondent
Medical Laser Research & Development Corp.
46 Clark St.
Malden,  MA  02148
Correspondent Contact DONNA BOURGELAIS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/09/1986
Decision Date 08/07/1986
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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