Identity
- Trade Name
- NON-CONTACT TONOMETER FDA UDI
- Generic Name
- Ophthalmic tonometer, line-powered FDA UDI
- Device Name
- The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye. FDA UDI
- Model / Reference
- FT-1000 FDA UDI
- Description
- The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582273612150 FDA UDI
- 510(k) Number
- K073087 FDA UDI
- FDA Product Code
- HKX FDA UDI
- GMDN Term
- Ophthalmic tonometer, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic tonometer, line-powered
Non-Contact Tonometer by Tomey Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer, line-powered.
- Model 30™ Tip and Membrane Assembly for Pneumatonometer — REICHERT INC. · Class II
- AUTO REF/KERATO/TONOMETER — Nidek, Inc. · Class II
- Falck Medical Multi-Function Applanation Tonometer — Falck Medical, Inc. · Class II
- Model 30™ Tip and Membrane Assembly for Pneumatonometer — REICHERT INC. · Class II
- VISUPLAN 500 — REICHERT INC. · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
- Reichert® 7 Auto Tonometer — REICHERT INC. · Class II
Cleared under the same submission
K073087 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tomey Corporation
Sources (1)
- FDA UDI bfb1d572-340e-4bdd-842e-abd00b2e1851 34 fields · synced May 30, 2026