Identity
- Trade Name
- EL LightWave EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Orthopedic, Active, Instrument, Electrosurgical, Bipolar, Suction Ablator EUDAMEDEL LightWave Suction Ablator FDA UDI
- Model / Reference
- EL-2000-S EUDAMEDFDA UDI
- Description
- EL LightWave Suction Ablator FDA UDI
Identifiers
- Catalog Number
- EL-2000-S FDA UDI
- Primary DI / UDI-DI
- 10653405059738 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10653405059738 EUDAMED
- 510(k) Number
- K083281 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02030109 RADIOFREQUENCY SURGERY HANDPIECES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
EL LightWave by Conmed 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-10653405059738 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED aa41d416-649e-4cb6-bca3-28385fb4ff55 61 fields · synced Jun 20, 2026
- FDA UDI 73259682-e798-49a5-badb-274b5adab39e 36 fields · synced May 30, 2026
- EUDAMED bd09e438-008b-408f-960b-6a05718b03d0 61 fields · synced Jun 20, 2026