Identity
- Trade Name
- Luneau FDA UDI
- Generic Name
- Ophthalmic tonometer tip cover FDA UDI
- Device Name
- 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
- Model / Reference
- Tonometer separation prisms L900 -box of 20 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
- 03664188000138 FDA UDI
- 510(k) Number
- K023838 FDA UDI
- FDA Product Code
- HKY FDA UDI
- GMDN Term
- Ophthalmic tonometer tip cover 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
Yes
FDA UDI
Single Use
Yes
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
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 — FDA UDI — listed in FDA GUDID — 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 (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 |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (1)
- FDA UDI ed4a9b04-4d56-444f-a6a2-c9f1d6019d6e 34 fields · synced May 30, 2026