FDA.reportPublic FDA data

NON-CONTACT TONOMETER

Primary DI
04582273611740
Brand
NON-CONTACT TONOMETER
Company
TOMEY CORPORATION.
Model
FT-1000
Device description
The NON-CONTACT TONOMETER FT-100 is a tonometer designed using a non-contact measurement system Air puff gently measures the intraocular pressure of the human eye.
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HKXTonometer, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582273611740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582273611740045822736117404582273611740

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).

Regulatory Flags#

DUNS number
696280002
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582273600263NON-CONTACT TONOMETERFT-10002022-04-01
04582273603691SPECULAR MICROSCOPEEM-40002022-04-01
04582273612150NON-CONTACT TONOMETERFT-10002016-09-21
04582273612167NON-CONTACT TONOMETERFT-10002016-10-18
04582273612822Specular MicroscopeEM-40002018-03-06
04582273604704Cornea/Anterior Segment OCTCASIA22023-06-07
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

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
04582273600263NON-CONTACT TONOMETERTOMEY CORPORATION.HKX2022-04-01
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