Etchonia Zerona Arms
510(k) K121690
Etchonia Zerona Arms is a Class II device made by Erchonia Corporation, cleared under FDA 510(k) K121690 on 23 Aug 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121690 | Date23 Aug 2012 | StatusActive |
Official records
- FDA 510(k) database K121690
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLI
- Device class
- Class II
- Regulation
- 21 CFR Part 878.5400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K121690
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Zerona AD ARC | ARC / ARC | 00858985006117 | — | On the market |
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