ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
FDA 510(k) clearance K112031 · decided 2011-09-13
Clearance details
- K-number
- K112031
- Device name
- ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
- Applicant
- Alma Lasers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-15
- Decision date
- 2011-09-13
- Days to decision
- 60 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Buffalo Grove, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.