XE-LITE

Lamp, Surgical

OPHTHALMIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for Xe-lite.

Pre-market Notification Details

Device IDK954263
510k NumberK954263
Device Name:XE-LITE
ClassificationLamp, Surgical
Applicant OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario,  CA Mej 3e5
ContactRishard Weitz
CorrespondentRishard Weitz
OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario,  CA Mej 3e5
Product CodeFTD  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-12
Decision Date1995-10-18

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