FDA.reportPublic FDA data

Eli Ezer

Primary DI
00851158007805
Brand
Eli Ezer
Company
U.S. OPHTHALMIC, L.L.C.
Model
EDR-H
Device description
Digital Refractor Ezer EDR-H
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKNRefractor, Manual, Non-Powered, Including Phoropter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKNRefractor, Manual, Non-Powered, Including PhoropterOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851158007805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851158007805008511580078058511580078050851158007805

GMDN Terms#

Term, Definition table
TermDefinition
Phoropter, electricAn electrically-powered ophthalmic device intended to be placed in front of a patient's eyes to assist with measuring the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an examination, typically to determine a patient's prescription for glasses. Also known as an automated or digital refractor, it typically consists of two mounted disk-like housings (head) which contain lenses of different characteristics. The optometrist changes the lenses and other settings via an electrical control unit, while asking the patient to read an eye chart and provide subjective feedback on which settings give best vision.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
166760392
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038195564EZ-TRI-3600EZ-TRI-36002025-02-19
00850038195557LuxVsionLDR-7800LDR-78002024-04-08
00851158007836Eli EzerEDR-9000 A2024-04-08
00850038195335Eli EzerEZ-OPH-3600-Halogen-Lamp2024-04-03
00850038195342Eli EzerEZ-OPH-3600- Led Lamp2024-04-03
00851158007621Eli EzerESL-Emerald-12024-01-25
00851158007638Eli EzerESL-Emerald-82024-01-25
00851158007645Eli EzerESL-Emerald-182024-01-25
00851158007652Eli EzerESL-Emerald-122024-01-25
00851158007669Eli EzerESL-Emerald-262024-01-25
00851158007683Eli EzerESL-Emerald-TN2024-01-25
00851158007003LuxVisionSL-11002016-08-16
00851158007010LuxVisionSL-14002016-08-16
00851158007027LuxVisionSL-20002016-08-16
00851158007034LuxVisionSL-7002016-08-16
00851158007041LuxVisionSL-8802016-08-16
00851158007126GilrasGR-7/LL2016-08-17
00851158007133GilrasGR-7/HL2016-08-17
00851158007140GilrasGR-7 2X/HL2016-08-17
00851158007157GilrasGR-7 2X/LL2016-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971922132299YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKN2026-05-01
00628308210473S4OptikINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210480LombartINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210497S4OptikINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210503LombartINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210510S4OptikINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210527LombartINNOVA Medical Ophthalmics IncHKN2026-03-31
04987669203552Fully Assisted Refraction SystemNIDEK CO.,LTD.HKN2026-03-27
00860014277542S4 OptikLombart Brothers, Inc.HKN2025-10-18
04540008310429RexxamREXXAM CO., LTD.HKN2025-10-17
00812559010238Ultramatic RX Master PhoropterREICHERT, INC.HKN2025-08-12
00812559010269Ultramatic RX Master PhoropterREICHERT, INC.HKN2025-08-12
00812559010290Illuminated PhoropterREICHERT, INC.HKN2025-08-12
00812559010320Illuminated PhoropterREICHERT, INC.HKN2025-08-12
00812559011716Phoropter VRxREICHERT, INC.HKN2025-08-12
00812559011730Phoropter VRxREICHERT, INC.HKN2025-08-12
00812559012263SightChek Digital PhoropterREICHERT, INC.HKN2025-08-12
00860014277504Advancing EyecareLombart Brothers, Inc.HKN2025-07-21
06972039971016MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKN2025-06-23
06972039971023MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKN2025-06-23
06972039971214MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKN2025-06-19
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosTOPCON CORPORATIONHKN2025-05-01
06971922132770YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKN2025-04-08
04560126268495SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000TOPCON CORPORATIONHKN2025-02-27
04560126268532COMPU VISION CV-5000TOPCON CORPORATIONHKN2025-02-27
04560126268549COMPU VISION CV-5000TOPCON CORPORATIONHKN2025-02-27
045601262685701DIAL CONTROLLER KB-50STOPCON CORPORATIONHKN2025-02-27
04560126268624POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)TOPCON CORPORATIONHKN2025-02-27
04560126268648POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE)TOPCON CORPORATIONHKN2025-02-27
03664188000077VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKN2025-01-02