Erchonia Zerona Z-Bed
FDA 510(k) clearance K220519 · decided 2022-03-24
Clearance details
- K-number
- K220519
- Device name
- Erchonia Zerona Z-Bed
- Applicant
- Erchonia Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-02-23
- Decision date
- 2022-03-24
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- OLI
- Device class
- 2
- Regulation number
- 878.5400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Melbourne, FL, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.