12.5MM PEYMAN WIDE FIELD YAG LASER LENS

Lens, Contact, Polymethylmethacrylate, Diagnostic

OCULAR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for 12.5mm Peyman Wide Field Yag Laser Lens.

Pre-market Notification Details

Device IDK872136
510k NumberK872136
Device Name:12.5MM PEYMAN WIDE FIELD YAG LASER LENS
ClassificationLens, Contact, Polymethylmethacrylate, Diagnostic
Applicant OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue,  WA  98005
ContactTamsin J Erickson
CorrespondentTamsin J Erickson
OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue,  WA  98005
Product CodeHJK  
CFR Regulation Number886.1385 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-03
Decision Date1987-06-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630238056007 K872136 000
00630238007320 K872136 000
00630238122245 K872136 000

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