ANAEYES OCT for system linkage

GUDID 03615020000496

ESSILOR INTERNATIONAL

Camera application software
Primary Device ID03615020000496
NIH Device Record Keyf65e990d-693e-42e8-bbc9-0f245ff7a815
Commercial Distribution StatusIn Commercial Distribution
Brand NameANAEYES OCT for system linkage
Version Model NumberANAEYES OCT
Company DUNS277373213
Company NameESSILOR INTERNATIONAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103615020000496 [Primary]

FDA Product Code

NFJSystem, Image Management, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-26
Device Publish Date2021-02-18

Devices Manufactured by ESSILOR INTERNATIONAL

03615020000038 - ALM5002023-10-11 This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed l
03615020000120 - ALM7002023-10-11 This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed l
03615020000236 - ALM8002023-10-11 This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed l
03615020000670 - Vision-C 6002023-10-06 Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
03615020000427 - Vision-R 8002023-09-19 Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
03615020000663 - Vision-R 7002023-09-19 Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
03615020000687 - Vision-S 7002023-09-19 Vision-S 700 is a Compact Refraction System used to determine the refractive error and binocular
03615020000694 - Vision-R 8002023-09-19 Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability

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