FDA.reportPublic FDA data

Digital C.R.P

Primary DI
03615020000397
Brand
Digital C.R.P
Company
ESSILOR INTERNATIONAL
Model
X81705
Device description
The digital Corneal Reflection Pupillometer (CRP) enables the Eyecare professional to obtain a measurement of a patient's monocular and binocular pupillary distance and displays them digitally.
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLGPupillometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLGPupillometer, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615020000397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615020000397036150200003973615020000397

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
817-262-3801John.Anderson@essilorusa.com

Regulatory Flags#

DUNS number
277373213
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615020000014AKR 550AKR5502026-02-23
03615020000113CP 550CP5502026-02-23
03615020000441AKR 800AKR1JR2026-02-23
03615024000003Essilor StellestEmmetropia2025-10-16
03615024000027Essilor Stellestmyopic correction2025-10-16
03615024000034Essilor StellestMyopia+Astigmatism2025-10-16
03615020000458WAVE ANALYZER MEDICA 800WAM8002023-07-25
03615020000380WAVE ANALYZER MEDICA 700 PLUSWAM7002016-09-23
03615020000267ESSILOR RETINA 400RETINA 4002016-09-23
03615020000465ESSILOR RETINA 800RET1IN2020-04-02
03615020000489OCT500OCT2JT2020-03-23
03615020000038ALM500ALM5002023-10-03
03615020000120ALM700ALM7002023-10-03
03615020000236ALM800ALM8002023-10-03
03615020000670Vision-C 600VRS0012023-09-28
03615020000427Vision-R 800V010122023-09-11
03615020000663Vision-R 700V011122023-09-11
03615020000687Vision-S 700VS010122023-09-11
03615020000694Vision-R 800V010142023-09-11
03615020000724Vision-R 700V011142023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250668607233ZEISS Mobile CentrationCarl Zeiss Vision GmbHHLG2026-01-15
00857901006620RETeval™L K C TECHNOLOGIES, INC.HLG2025-07-01
00857901006637RETeval™L K C TECHNOLOGIES, INC.HLG2025-07-01
00850010118024NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118086NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118093NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118109NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118116NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118123NeurOpticsNeuroptics, Inc.HLG2024-03-11
04049584022011Vissard 3D, linear polarizedOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLG2022-12-01
04049584022158Vissard 3D, circular polarizedOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLG2022-12-01
04049584025166Vissard RGOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLG2022-12-01
03665023000627NL-2-DEMIDMEDHLG2022-06-10
00857901006392UTASL K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006415UTASL K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006439RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006446RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006453RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006460RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006477RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00850010118000NeurOpticsNeuroptics, Inc.HLG2021-04-06
00850010118017NeurOpticsNeuroptics, Inc.HLG2021-04-06
00850010118062NeurOpticsNeuroptics, Inc.HLG2021-04-06
00850010118079NeurOpticsNeuroptics, Inc.HLG2020-10-27
10850010118038NeurOpticsNeuroptics, Inc.HLG2020-10-27
03665023000184NL-2IDMEDHLG2020-01-24
03665023000191NL-MUIDMEDHLG2020-01-24
03665023000429STA-W2IDMEDHLG2020-01-24
04987669100837PD MeterNIDEK CO.,LTD.HLG2018-04-20
00857901006019RETeval™L K C TECHNOLOGIES, INC.HLG2016-03-11