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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 K983984
Device Name COOLTOUCH V ND:YAG
Applicant
Laser Aesthetics, Inc.
11802 Kemper Rd.
Auburn,  CA  95603
Applicant Contact JONATHAN M BAUMGARDNER
Correspondent
Laser Aesthetics, Inc.
11802 Kemper Rd.
Auburn,  CA  95603
Correspondent Contact JONATHAN M BAUMGARDNER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/09/1998
Decision Date 06/07/1999
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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