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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 K003614
Device Name LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
Applicant
Coherent Star
1249 Quarry Ln., Suite 100
Pleasanton,  CA  94566
Applicant Contact ILIRIJA ENCINAS
Correspondent
Coherent Star
1249 Quarry Ln., Suite 100
Pleasanton,  CA  94566
Correspondent Contact ILIRIJA ENCINAS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/22/2000
Decision Date 03/13/2001
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
Recalls CDRH Recalls
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