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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 K950493
Device Name PHOTODERM VL.
Applicant
Esc, Energy Systems Corp.
Matam Science & Industry Park
Haifa, Israel,  IL
Applicant Contact LYNN GOLUIMBIC
Correspondent
Esc, Energy Systems Corp.
Matam Science & Industry Park
Haifa, Israel,  IL
Correspondent Contact LYNN GOLUIMBIC
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/06/1995
Decision Date 08/07/1995
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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