ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
FDA 510(k) clearance K100415 · decided 2010-04-21
Clearance details
- K-number
- K100415
- Device name
- ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
- Applicant
- Lumenis
- Decision
- Substantially Equivalent
- Date received
- 2010-02-16
- Decision date
- 2010-04-21
- Days to decision
- 64 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
- Kfar Saba, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20 recall (Z-0301-2017) | Lumenis Limited | 2016-10-23 |
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 |