FDA.reportPublic FDA data

Icare HOME tonometer

Primary DI
06430033850237
Brand
Icare HOME tonometer
Company
ICARE FINLAND OY
Model
TA022
Published
2017-03-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKXTonometer, Ac-Powered
HKYTonometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKXTonometer, Ac-PoweredOphthalmic2
HKYTonometer, ManualOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163343000Icare HOME tonometerIcare Finland OY2017-03-21HKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430033850237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430033850237064300338502376430033850237

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, battery-operatedAn ophthalmic, battery-powered, measuring instrument designed for determining the 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) which is expressed in millimetre(s) of mercury (mmHg). This hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients.

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
06430033852415iCare IC100TA011240US2025-12-04
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
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
04719872711230MiiSMEDIMAGING INTEGRATED SOLUTION INC.HKX2026-04-29
04719876420046TonoVueCRYSTALVUE MEDICAL CORPORATIONHKX2026-04-15
00841668146477KATENAKATENA PRODUCTS, INC.HKY2026-03-02
10841668146474KATENAKATENA PRODUCTS, INC.HKY2026-03-02
06430033851920iCare ST500ICARE FINLAND OYHKX2025-12-05
06430033851920iCare ST500ICARE FINLAND OYHKY2025-12-05
06430033852415iCare IC100ICARE FINLAND OYHKY2025-12-04
06430033852514iCare IC200ICARE FINLAND OYHKY2025-12-04
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONHKX2025-11-17
07350023774307CalcibonBiomet Biologics, LLCHKX2025-10-09
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
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKX2025-03-11
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
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 OYHKX2024-11-07
06430033851784ST500 SmartCradleICARE FINLAND OYHKY2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKX2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKY2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKX2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKY2024-11-07