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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 K992597
Device Name LORAD LT-100 LASER TREATMENT SYSTEM
Applicant
Focus Medical, LLC
39 Silver Spring Park
Ridgefield,  CT  06877
Applicant Contact JOHN LEE
Correspondent
Focus Medical, LLC
39 Silver Spring Park
Ridgefield,  CT  06877
Correspondent Contact JOHN LEE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/03/1999
Decision Date 04/24/2000
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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