FDA.reportPublic FDA data

i.Profiler plus

Primary DI
04250668606755
Brand
i.Profiler plus
Company
Carl Zeiss Vision GmbH
Model
000000-2358-727
Catalog number
000000-2358-727
Device description
N/A
Published
2021-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKORefractometer, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKORefractometer, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250668606755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250668606755042506686067554250668606755

GMDN Terms#

Term, Definition table
TermDefinition
Automated ophthalmic refractometerAn electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0701 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity095 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(423)598-2680jahmal.cannon@zeiss.com

Regulatory Flags#

DUNS number
333928146
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
04250668607202VISUREF 600000000-2572-4242026-04-24
04250668607233ZEISS Mobile Centration000000-2750-321000000-2750-3212026-01-15
04250668606748VISU360000000-1011-377000000-1011-3772021-01-01
04250668606045VISUSCREEN 100 Compact000000-2522-536000000-2522-5362023-05-30
04250668606052VISUCORE 500 Refractor000000-2522-537000000-2522-5372023-05-30
04250668606618VISUCONSULT 500000000-2265-586000000-2265-5862021-01-01
04250668607172i.Terminal go000000-2408-309000000-2408-3092022-12-08
04250668606649i.Terminal mobile000000-2120-340000000-2120-3402021-01-01
04250668606687VISUFIT 1000000000-2351-293000000-2351-2932021-01-01
04250668606700i.Terminal 2 Station000000-2433-519000000-2433-5192021-01-01
04250668606625i.Profiler plus000000-1005-825000000-1005-8252021-01-01
04250668606663VISUFIT 1000 Platform000000-2194-446000000-2194-4462021-01-01
04250668606694i.Terminal 2000000-1898-991000000-1898-9912021-01-01
04250668606670Avatar Generation000000-2351-295000000-2351-2952021-01-01
04250668606724VISUSCREEN 500000000-2087-230000000-2087-2302021-01-01
04250668606717i.Terminal 2000000-2408-310000000-2408-3102021-01-22
04250668606731VISUSCREEN 100000000-2069-910000000-2069-9102021-01-01
04250668606632ATLAS Review for i. Profiler plus000000-2360-422000000-2360-4222021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972039971092MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKO2026-06-03
06971922136334YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKO2026-04-25
03615020000014AKR 550ESSILOR INTERNATIONALHKO2026-02-23
03615020000441AKR 800ESSILOR INTERNATIONALHKO2026-02-23
08800019600954Vision ScreenerHuvitz Co., Ltd.HKO2026-02-13
B43050085700GoCheck KidsGobiquity, Inc.HKO2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04560126269188AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-11-21
B43071000030GoCheck MultiScreenerGobiquity, Inc.HKO2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HKO2025-11-04
04560126269140AUTO KERATO-REFRACTOMETER KR-800TOPCON CORPORATIONHKO2025-10-31
04560126269164AUTO REFRACTOMETER RM-800TOPCON CORPORATIONHKO2025-10-31
B43050085600GoCheck KidsGobiquity, Inc.HKO2025-10-22
00860014277528S4Optik REF-K2000Lombart Brothers, Inc.HKO2025-10-18
04540008310030RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310320RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310436RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310443RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310603RexxamREXXAM CO., LTD.HKO2025-10-17
06973211071869Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18
06973211071876Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18
00812559012249OptochekPlusREICHERT, INC.HKO2025-08-12
04571130283381AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-06-19
04571130283404AUTO KERATO-REFRACTOMETER KR-800PATOPCON CORPORATIONHKO2025-05-12
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosTOPCON CORPORATIONHKO2025-05-01
04571130283367AUTO KERATO-REFRACTOMETER KR-800ATOPCON CORPORATIONHKO2025-04-15
B43050085500GoCheck KidsGobiquity, Inc.HKO2025-03-20
03664188000169VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKO2025-01-02
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSHKO2025-01-02