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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 K993154
Device Name LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM
Applicant
A.R.C. Laser Corp.
2417 S. 3850 W.
Salt Lake City,  UT  84120
Applicant Contact DANIEL HOEFER
Correspondent
A.R.C. Laser Corp.
2417 S. 3850 W.
Salt Lake City,  UT  84120
Correspondent Contact DANIEL HOEFER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HQC  
Date Received09/21/1999
Decision Date 06/29/2000
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
Recalls CDRH Recalls
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