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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 K950019
Device Name THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-100
Applicant
Thermolase Corp.
9550 Distribution Ave.
San Diego,  CA  92121
Applicant Contact KENNETH Y TANG
Correspondent
Thermolase Corp.
9550 Distribution Ave.
San Diego,  CA  92121
Correspondent Contact KENNETH Y TANG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/03/1995
Decision Date 04/03/1995
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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