Identity
- Trade Name
- TONOJET EUDAMEDLuneau FDA UDI
- Generic Name
- Ophthalmic tonometer tip cover FDA UDI
- Device Name
- Sterile tonometer prisms EUDAMEDThe separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye. FDA UDI
- Model / Reference
- L900 EUDAMEDTonometer separation prisms L900 -box of 100 FDA UDI
- Description
- The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000107 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03664188000107 EUDAMED
- 510(k) Number
- K023838 FDA UDI
- FDA Product Code
- HKY FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic tonometer tip cover FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic tonometer tip cover
Luneau by Luneau Technology Operations — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer tip cover.
- Ocu-Film® +" — REICHERT INC. · Class II
- Automated Ophthalmics Softips — Automated Ophthalmics, Inc. · Class II
- Ocu-Film® +" — REICHERT INC. · Class II
- FMAT1 Prism B — Falck Medical, Inc. · Class II
- Luneau — LUNEAU TECHNOLOGY OPERATIONS · Class II
Cleared under the same submission
K023838 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (2)
- FDA UDI 1a693d80-a788-4874-85e5-8ea9a91822b4 34 fields · synced Jun 18, 2026
- EUDAMED 8d9c12cc-6370-46de-a179-7c4663aaade9 61 fields · synced Jun 18, 2026