FDA.reportPublic FDA data

iCare IC100

Primary DI
06430033852415
Brand
iCare IC100
Company
ICARE FINLAND OY
Model
TA011
Catalog number
240US
Device description
The iCare IC100 tonometer is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidlyand without an anesthetic. The iCare IC100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
Published
2025-12-04
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
HKYTonometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKYTonometer, ManualOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430033852415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430033852415064300338524156430033852415

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, professionalAn ophthalmic, electrically-powered device intended to be used by a healthcare professional to measure intraocular pressure (IOP) by exerting an external force against the eye, which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation), typically for the diagnosis of glaucoma. It may have a light contact with the eye, have a bench-top or hand-held design, and use various techniques (e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
651755092
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430033851920iCare ST500TA042025-12-05
06430033852514iCare IC200TA031250US2025-12-04
16430033850623Probes for HOMETP0222017-03-24
06430033851784ST500 SmartCradleTX022024-11-07
06430033851791ST500 AdapterTD012024-11-07
06430033851807ST500 RemoteTR012024-11-07
06430033851883iCare ST500TA042024-11-07
06430033851074Icare HOME tonometerTA0222020-05-11
06430033850060Icare TA01iTA01i2016-09-23
06430033851098iCare PATIENT2TS052024-04-23
06430033851104iCare PATIENT2TS052024-04-23
06430033850985Icare PATIENTTS042020-05-11
06430033851036Icare ic200TA0312020-01-17
06430033850237Icare HOME tonometerTA0222017-03-24
06430033851463iCare IC200TA0312023-06-20
06430033850947Probes for HOMETP0222020-04-15
06430033850565Icare tonometer probesTP01s2016-12-01
06430033850626Probes for HOMETP0222017-03-24
06430033851456iCare HOME2TA0232022-02-08
06430033850961Icare CLINICTS022020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668146477KATENAKATENA PRODUCTS, INC.HKY2026-03-02
10841668146474KATENAKATENA PRODUCTS, INC.HKY2026-03-02
06430033851920iCare ST500ICARE FINLAND OYHKY2025-12-05
06430033852514iCare IC200ICARE FINLAND OYHKY2025-12-04
00812559012485" Ocu-Film® +"""REICHERT, INC.HKY2025-08-15
00812559012492"Ocu-Film® +"""REICHERT, INC.HKY2025-08-14
00812559012454Ocu-Dot® Tonometer Probes - 100 CountREICHERT, INC.HKY2025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, RechargeableREICHERT, INC.HKY2025-08-12
00812559011945Tono-Vera® Tonometer Starter Kit, AA BatteryREICHERT, INC.HKY2025-08-12
00812559012324Ocu-Dot® Tonometer Probes - 100 CountREICHERT, INC.HKY2025-08-12
00757770407309Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770408856Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770417629Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770420803Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770426867Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
06430033851784ST500 SmartCradleICARE FINLAND OYHKY2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKY2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKY2024-11-07
06430033851883iCare ST500ICARE FINLAND OYHKY2024-11-07
00887482112366Symmetry Allen-SchiotzASPEN SURGICAL PRODUCTS, INC.HKY2024-08-20
06430033851098iCare PATIENT2ICARE FINLAND OYHKY2024-04-23
06430033851104iCare PATIENT2ICARE FINLAND OYHKY2024-04-23
06430033851463iCare IC200ICARE FINLAND OYHKY2023-06-20
08800019600411Applanation Tonometer HT-5000Huvitz Co., Ltd.HKY2023-06-12
04560323648564TAKAGITAKAGI SEIKO CO.,LTD.HKY2023-06-09
03664188000138LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
03664188000114LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
00860000603805Automated Ophthalmics Softips AUTOMATED OPHTHALMICS, INC.HKY2022-11-17
00860412001541CATSZIEN MEDICAL TECHNOLOGIES, INC.HKY2022-10-12
00860412001558CATSZIEN MEDICAL TECHNOLOGIES, INC.HKY2022-10-12