EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
FDA 510(k) clearance K041957 · decided 2004-12-01
Clearance details
- K-number
- K041957
- Device name
- EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
- Applicant
- Diomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-21
- Decision date
- 2004-12-01
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Reading, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box co recall (Z-1819-2022) | Angiodynamics, Inc. | 2022-09-27 |