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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 K960086
Device Name DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
Applicant
Slt-J , Ltd.
5848 Price Rd.
Milford,  OH  45150
Applicant Contact MICHAEL JOHNSON
Correspondent
Slt-J , Ltd.
5848 Price Rd.
Milford,  OH  45150
Correspondent Contact MICHAEL JOHNSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/11/1996
Decision Date 06/03/1996
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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