Identity
- Trade Name
- Solo EUDAMEDFDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- Tango EUDAMEDSolo EUDAMED
- Model / Reference
- LT5106-T EUDAMEDLT5106-S EUDAMEDFDA UDILT5106‐S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09342395000069 EUDAMEDFDA UDI
- Basic UDI-DI
- 9342395YAGSLT6M EUDAMEDB-09342395000069 EUDAMED
- 510(k) Number
- K212630 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
- GMDN Term
- Ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Solo by Ellex Medical Pty Ltd — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 9342395YAGSLT6M | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 9342395YAGSLT6M | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ellex Medical Pty Ltd
- EUDAMED SRN
- AU-MF-000004802
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (3)
- EUDAMED fcbe7a7f-02b1-49c1-88fb-3583b5dad277 61 fields · synced Jul 22, 2026
- EUDAMED 9e501d7d-835d-4515-b5d3-a505141d77cd 61 fields · synced May 17, 2026
- FDA UDI 11b3b4fa-4251-46ed-be7e-db87cd9af1cb 34 fields · synced May 30, 2026