LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
FDA 510(k) clearance K011703 · decided 2001-08-29
Clearance details
- K-number
- K011703
- Device name
- LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
- Applicant
- Lumenis
- Decision
- Substantially Equivalent
- Date received
- 2001-06-01
- Decision date
- 2001-08-29
- Days to decision
- 89 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
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, recall (Z-0585-2008) | Lumenis, Inc. | 2008-04-09 |
| Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft recall (Z-0028-2007) | Lumenis Inc. | 2006-10-12 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COHERENT OPAL PHOTOACTIVATOR (P990049/S001) | Lumenis | 2001-09-27 |
| COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM (P990049) | Lumenis | 2000-04-12 |