Vista Ophthalmics Vitrectomy Probe

Vitrectomy, Instrument Cutter

Vista Ophthalmics LLC

The following data is part of a premarket notification filed by Vista Ophthalmics Llc with the FDA for Vista Ophthalmics Vitrectomy Probe.

Pre-market Notification Details

Device IDK220030
510k NumberK220030
Device Name:Vista Ophthalmics Vitrectomy Probe
ClassificationVitrectomy, Instrument Cutter
Applicant Vista Ophthalmics LLC 23510 Kingsland Blvd. Suite 200 Katy,  TX  77494
ContactDon Knowles
CorrespondentDebe Deck
Regulatory Pathways Group Inc. 340 S. Lemon Ave, #2471 Walnut,  CA  91789
Product CodeMLZ  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-05
Decision Date2022-05-04

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