LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR
FDA 510(k) clearance K050923 · decided 2005-05-18
Clearance details
- K-number
- K050923
- Device name
- LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR
- Applicant
- Conmed Linvatec
- Decision
- Substantially Equivalent
- Date received
- 2005-04-13
- Decision date
- 2005-05-18
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JOS
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, recall (Z-2051-2009) | Linvatec Corp. dba ConMed Linvatec | 2009-09-09 |