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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Ac-Powered
510(k) Number K933556
Device Name EH-270 CORNEAL TOPOGRAPHER
Applicant
Visioptic, Inc.
3300 S. Gessner,
Suite 253
Houston,  TX  77063
Applicant Contact WALTER JEFFERSON
Correspondent
Visioptic, Inc.
3300 S. Gessner,
Suite 253
Houston,  TX  77063
Correspondent Contact WALTER JEFFERSON
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received07/21/1993
Decision Date 11/02/1993
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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