Identity
- Trade Name
- Ellex FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- ACC. SAFETY FILTER, ZEISS/MOELLER, FIXED (SOLITAIRE) FDA UDI
- Model / Reference
- 6339520 FDA UDI
- Description
- ACC. SAFETY FILTER, ZEISS/MOELLER, FIXED (SOLITAIRE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09342395000694 FDA UDI
- 510(k) Number
- K041598 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 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
No
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 solid-state laser system
Ellex by Ellex Medical Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041598 also covers:
- Ellex — ELLEX MEDICAL PTY LTD
- Ellex — ELLEX MEDICAL PTY LTD
- Ellex — ELLEX MEDICAL PTY LTD
- Ellex — ELLEX MEDICAL PTY LTD
- Ellex — ELLEX MEDICAL PTY LTD
- Ellex — ELLEX MEDICAL PTY LTD
- Ellex — ELLEX MEDICAL PTY LTD
- Ellex — ELLEX MEDICAL PTY LTD
- Ellex — ELLEX MEDICAL PTY LTD
- Ellex — ELLEX MEDICAL PTY LTD
- SOLITAIRE — ELLEX MEDICAL PTY LTD
- Solitaire — ELLEX MEDICAL PTY LTD
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
- Ellex Medical Pty Ltd
Sources (1)
- FDA UDI bb8b75b4-6fd0-4313-9cdb-52434ed8a044 35 fields · synced May 30, 2026