Identity
- Trade Name
- VISIONIX FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- ophthalmic slit lamp FDA UDI
- Model / Reference
- VX75 - 5x conv FDA UDI
- Description
- ophthalmic slit lamp FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000763 FDA UDI
- 510(k) Number
- K992836 FDA UDI
- FDA Product Code
- HJO FDA UDI
- GMDN Term
- Ophthalmic examination slit lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1850 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 examination slit lamp
Visionix by Luneau Technology Operations — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic examination slit lamp.
- Mediworks — SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. · Class II
- ILLUMINIX — Illuminix Industries LLC · Class II
- Visionix — RIGHT MFG. CO., LTD. · Class II
- Slit Lamp BQ 900 — Haag-Streit AG · Class II
- S4 OPTIK — COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL · Class II
- SLH 5XC 6V TBL USA — KEELER LIMITED · Class II
- SLH 5XC 6V TBL — KEELER LIMITED · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
Cleared under the same submission
K992836 also covers:
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS
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
- Luneau Technology Operations
Sources (1)
- FDA UDI 1a9d6e40-ae37-4279-a72f-68a60a831da3 34 fields · synced May 31, 2026