Identity
- Trade Name
- Lpulsa SYL9000 EUDAMEDSYL-9000 YAG Laser FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- Ophthalmic YAG Laser System and Accessories EUDAMED
- Model / Reference
- Lpulsa SYL9000 EUDAMEDYL0027 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04712826771069 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712826771069 EUDAMED
- 510(k) Number
- K990075 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Z12011011,Z12011017 EUDAMED
- GMDN Term
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Dimensions & Sizes
- Size
- Weight — 28 Kilogram FDA UDI
Lpulsa SYL9000 by Lightmed Corporation — Class IIb — 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-04712826771069 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Lightmed Corporation
- EUDAMED SRN
- TW-MF-000027493
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0cfc060e-8b8f-44ce-8896-01d2d12cfa1b 61 fields · synced Jul 11, 2026
- FDA UDI 50ba0e6f-324d-494b-b345-8051a57191c3 34 fields · synced May 29, 2026