LunulaLaser
FDA 510(k) clearance K153164 · decided 2016-06-03
Clearance details
- K-number
- K153164
- Device name
- LunulaLaser
- Applicant
- Erchonia Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-02
- Decision date
- 2016-06-03
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- PDZ
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mckinney, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.