FDA.reportPublic FDA data

NON-CONTACT TONOMETER

Primary DI
04582273600263
Brand
NON-CONTACT TONOMETER
Company
TOMEY CORPORATION.
Model
FT-1000
Published
2022-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKXTonometer, Ac-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073087000NON-CONTACT TONOMETER, MODEL FT-1000Tomey Corporation2008-11-18HKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582273612150PreviousGS10
04582273600263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582273612150045822736121504582273612150
04582273600263045822736002634582273600263

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, line-poweredAn ophthalmic, line-powered, measuring instrument used 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). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
696280002
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582273604704Cornea/Anterior Segment OCTCASIA22023-06-07
04582273603691SPECULAR MICROSCOPEEM-40002022-04-01
04582273612822Specular MicroscopeEM-40002018-03-06
04582273600218AUTO REFKERATOMETERRC-50002022-04-01
04582273600256AUTO REF-TOPOGRAPHERRT-70002022-04-01
04582273603714Topographic Modeling SystemTMS-4N2022-04-01
04582273604162Auto LensmeterTL-70002022-04-01
04582273611788AUTO REFKERATOMETERRC-8002022-04-01
04582273612679Auto LensmeterTL-60002022-04-01
04582273612242AUTO REFKERATOMETERRC-50002020-10-30
04582273612273AUTO REFKERATOMETERRC-8002020-10-30
04582273612297AUTO REF-TOPOGRAPHERRT-70002020-10-30
04582273612099TOPOGRAPHIC MODELING SYSTEMTMS-4N2020-10-30
04582273612129TOPOGRAPHIC MODELING SYSTEMTMS-4N2020-10-30
04582273612402AUTO LENSMETERTL-1002020-10-30
04582273612655AUTO LENSMETERTL-70002020-10-30
04582273612686AUTO LENSMETERTL-60002020-10-30
04582273612167NON-CONTACT TONOMETERFT-10002016-10-18
04582273611740NON-CONTACT TONOMETERFT-10002016-10-18
04582273612150NON-CONTACT TONOMETERFT-10002016-09-21

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
06430033851920iCare ST500ICARE FINLAND OYHKX2025-12-05
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONHKX2025-11-17
07350023774307CalcibonBiomet Biologics, LLCHKX2025-10-09
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKX2025-03-11
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
06430033851784ST500 SmartCradleICARE FINLAND OYHKX2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKX2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKX2024-11-07
06430033851883iCare ST500ICARE FINLAND OYHKX2024-11-07
00851158007683Eli EzerU.S. OPHTHALMIC, L.L.C.HKX2024-01-25
04547451026686INAMI INAMI & CO., LTD.HKX2023-07-27
04547451026709INAMIINAMI & CO., LTD.HKX2023-07-27
03615020000458WAVE ANALYZER MEDICA 800ESSILOR INTERNATIONALHKX2023-07-25
08800019600411Applanation Tonometer HT-5000Huvitz Co., Ltd.HKX2023-06-12
08800019600435Non-contact Tonometer HNT-1PHuvitz Co., Ltd.HKX2023-06-12
08800019600558Auto Tono/Refracto/Kerato/Pachymeter HTR-1AHuvitz Co., Ltd.HKX2023-06-12
03664188000145Visionix VX650LUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000923RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000930RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
04047844051269DIPLOMAT Def.SIGNUS Medizintechnik GmbHHKX2022-06-20
04047844051276DIPLOMAT Def.SIGNUS Medizintechnik GmbHHKX2022-06-20
00851158007706Eli EzerU.S. OPHTHALMIC, L.L.C.HKX2021-01-04
M6333974340JEDMEDJEDMED INSTRUMENT COMPANYHKX2020-09-01
03664188000039VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25
03664188000046VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25
03664188000909VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25