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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 K001527
Device Name FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
Applicant
Fotona D.D.
Stegne 7
Ljubljana,  SI 1210
Applicant Contact MOJCA VALJAVEC
Correspondent
Fotona D.D.
Stegne 7
Ljubljana,  SI 1210
Correspondent Contact MOJCA VALJAVEC
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/16/2000
Decision Date 07/27/2000
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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