ARGON/KRYPTON ION LASER PHOTOCOAGULA

Laser, Ophthalmic

NIDEK, INC.

The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Argon/krypton Ion Laser Photocoagula.

Pre-market Notification Details

Device IDK834305
510k NumberK834305
Device Name:ARGON/KRYPTON ION LASER PHOTOCOAGULA
ClassificationLaser, Ophthalmic
Applicant NIDEK, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-28
Decision Date1984-03-16

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