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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photocoagulator And Accessories
510(k) Number K923531
Device Name OPTOSCALPEL I LASER SYSTEM
Applicant
Optomed Corp.
8920 Business Park Dr.
Suite 250
Austin,  TX  78759
Applicant Contact SHAHRIAR GHAFFARI
Correspondent
Optomed Corp.
8920 Business Park Dr.
Suite 250
Austin,  TX  78759
Correspondent Contact SHAHRIAR GHAFFARI
Regulation Number886.4690
Classification Product Code
HQB  
Date Received07/16/1992
Decision Date 11/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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