LunulaLaser— 510(k) K153164
Substantially EquivalentErchonia Medical, Inc.
FDA 510(k) clearance K153164 for LunulaLaser, Substantially Equivalent on 2016-06-03. Applicant: Erchonia Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Erchonia Medical, Inc.
- Product code
- Code PDZ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mckinney, TX, US
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