Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers

Photocoagulator And Accessories

Vortex Surgical Inc

The following data is part of a premarket notification filed by Vortex Surgical Inc with the FDA for Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers.

Pre-market Notification Details

Device IDK220263
510k NumberK220263
Device Name:Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
ClassificationPhotocoagulator And Accessories
Applicant Vortex Surgical Inc 680 Crown Industrial Ct Ste F Chesterfield,  MO  63005
ContactAndrew Ritts
CorrespondentAndrew Ritts
Vortex Surgical Inc 680 Crown Industrial Ct Ste F Chesterfield,  MO  63005
Product CodeHQB  
CFR Regulation Number886.4690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-31
Decision Date2022-11-03

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