Lumenis M22 System
FDA 510(k) clearance K142860 · decided 2015-01-21
Clearance details
- K-number
- K142860
- Device name
- Lumenis M22 System
- Applicant
- Lumenis, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-10-01
- Decision date
- 2015-01-21
- Days to decision
- 112 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
- Yokneam, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-10 recall (Z-1669-2016) | Lumenis Ltd | 2016-05-13 |