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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 K030342
Device Name LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
Applicant
Lumenis, Ltd.
2400 Condensa St.
Santa Clara,  CA  95051
Applicant Contact ANDREA L RUTH
Correspondent
Lumenis, Ltd.
2400 Condensa St.
Santa Clara,  CA  95051
Correspondent Contact ANDREA L RUTH
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/03/2003
Decision Date 07/17/2003
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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