DI-RHEX OPHTHALMIC DIATHERMY SYSTEM

Apparatus, Cautery, Radiofrequency, Ac-powered

OPHTHALMIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for Di-rhex Ophthalmic Diathermy System.

Pre-market Notification Details

Device IDK990064
510k NumberK990064
Device Name:DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
ClassificationApparatus, Cautery, Radiofrequency, Ac-powered
Applicant OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario,  CA Mej 3e5
ContactGeorge Myers
CorrespondentGeorge Myers
OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario,  CA Mej 3e5
Product CodeHQR  
CFR Regulation Number886.4100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-08
Decision Date1999-04-04
Summary:summary

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