FDA.reportPublic FDA data

PD-1

Primary DI
00628308210558
Brand
PD-1
Company
INNOVA Medical Ophthalmics Inc
Model
PD-1
Device description
Pupilometer
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HLHPupillometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLHPupillometer, ManualOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628308210558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628308210558006283082105586283082105580628308210558

GMDN Terms#

Term, Definition table
TermDefinition
Interpupillary distance meter, electronicAn electrically-powered, ophthalmic instrument, intended for use by a healthcare provider in a clinical setting to objectively measure the distance between the pupils of eyes, typically to ensure proper alignment when fitting spectacles. Also known as a pupilometer, it is a hand-held device with controls and display(s) intended to show the distance measurement.

Regulatory Flags#

DUNS number
243325332
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
00628308210435S4OptikTA1-550-NA2026-03-31
00628308210459S4OptikTA1-552-NA2026-03-31
00628308210473S4OptikRT-600-SN-GRY2026-03-31
00628308210480LombartRT-600-LN-GRY2026-03-31
00628308210497S4OptikRT-600-SN-BLK2026-03-31
00628308210503LombartRT-600-LN-BLK2026-03-31
00628308210510S4OptikRT-600-SP-BLK2026-03-31
00628308210527LombartRT-600-LP-BLK2026-03-31
00628308210534LombartPD-12026-03-31
00628308210541S4OptikPD-12026-03-31
00628308210336S4 OPTIKTA1INTT-36172025-08-21
00628308210343S4 OPTIKTA1INTT-2E2025-08-21
00628308210350S4 OPTIKTA1INTT-12025-08-21
00628308210367S4 OPTIK400-1002025-08-21
00628308210374S4 OPTIK222-0012025-08-21
00628308210381S4 OPTIK280-0002025-08-21
00628308210398S4 OPTIK281-0002025-08-21
00628308210305S4 OptikTA1S4-2UP2025-06-04
00628308210312S4 OptikTA1S4-2UP-Lx2025-06-04
00628308210329S4 OptikTA1S4-3UP2025-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628308210534LombartINNOVA Medical Ophthalmics IncHLH2026-03-31
00628308210541S4OptikINNOVA Medical Ophthalmics IncHLH2026-03-31
00812559010580PDM Digital PD MeterREICHERT, INC.HLH2025-08-12
00860014277511Advancing EyecareLombart Brothers, Inc.HLH2025-07-28
06971922134064YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLH2022-04-21
06971922134026YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLH2022-03-21
06971922130080PupilometerChongqing Yeasn Science & Technology Co.,Ltd.HLH2020-10-22