ERCHONIA ML SCANNER (MLS)
FDA 510(k) clearance DEN090008 · decided 2010-08-24
Clearance details
- K-number
- DEN090008
- Device name
- ERCHONIA ML SCANNER (MLS)
- Applicant
- Erchonia Medical
- Decision
- Unknown
- Date received
- 2009-01-05
- Decision date
- 2010-08-24
- Days to decision
- 596 days
- Clearance type
- Post-NSE
- Product code
- OLI
- Device class
- 2
- Regulation number
- 878.5400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Greenwood Village, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.