FDA.reportPublic FDA data

Phoropter VRx

Primary DI
00812559011730
Brand
Phoropter VRx
Company
REICHERT, INC.
Model
16242
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00812559011730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812559011730008125590117308125590117300812559011730

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic ophthalmic prismA transparent geometrical device intended to use light refraction principles to assist in the diagnosis of visual problems, especially those associated with ocular muscles (e.g., reduced convergence or accommodation). It is available in various forms such as a bar with multiple prisms of graduated powers, or a single prism on a handle. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
126650253
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
00812559010580PDM Digital PD Meter150202025-08-12
00812559010115Ocu-Film +2306512016-09-22
00812559012096Ocu-Film +2306532016-09-22
00812559012485" Ocu-Film® +"""2306532025-08-15
00812559012492"Ocu-Film® +"""2306512025-08-14
00812559011136UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559012454Ocu-Dot® Tonometer Probes - 100 Count163182025-08-12
00812559010238Ultramatic RX Master Phoropter11625B2025-08-12
00812559010269Ultramatic RX Master Phoropter11635B2025-08-12
00812559010290Illuminated Phoropter116362025-08-12
00812559010320Illuminated Phoropter116372025-08-12
00812559010559TF50 Trial Frame150102025-08-12
00812559010566TS75 Trial Lens150152025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, Rechargeable163062025-08-12
00812559011143UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559011419Quebec® Manual Darkfield Colony Counter133325002025-08-12
00812559011440Quebec® Digital Darkfield Colony Counter133327002025-08-12
00812559011495Reichert® Digital USG-Chek139400192025-08-12
00812559011518Clinical Refractometers Reichert® Digital Clinic-Chek139400212025-08-12
00812559011716Phoropter VRx162412025-08-12

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
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
06971922132558YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKN2024-11-30