Identity
- Trade Name
- Ophthalmed® laser probe EUDAMEDNA FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- ILLUMINATED LASER PROBE 23g ANGLED TIP WITH LASER IRIDEX AND ILLUMINATION ALCON® STANDARD EUDAMED
- Model / Reference
- B578203 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811682033794 EUDAMEDM735B5782031 FDA UDI
- Basic UDI-DI
- B-00811682033794 EUDAMED
- 510(k) Number
- K050807 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Q02040301 OCULAR ENDOPHOTOCOAGULATION FIBERS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- Germany 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
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
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
Dimensions & Sizes
- Size
- Needle Gauge — 23 Gauge FDA UDI
Ophthalmed® laser probe by Ophthalmed Llc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00811682033794 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ophthalmed Llc
- EUDAMED SRN
- US-MF-000032432
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED c733b4b8-4de5-4f44-86b8-bb4bd89bf82b 61 fields · synced May 31, 2026
- FDA UDI 858fd830-6569-4f29-b031-7a2639dfbc82 35 fields · synced May 22, 2026