Zerona Z6 SHR
Zerona Z6 SHR is a Class II device made by Erchonia Corporation, cleared under FDA 510(k) K162578 on 16 Dec 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00858985006124), 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 | NumberK162578 | Date16 Dec 2016 | StatusActive |
| United States | GUDID listing | Number00858985006124 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00858985006124
- FDA 510(k) database K162578
Across registries
- FDA 510(k) K162578 decided 16 Dec 2016 Active
- FDA GUDID UDI-DI 00858985006124 listed 24 Sep 2016 Listed
Timeline
- Listed FDA GUDID 00858985006124
- Cleared FDA 510(k) K162578
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zerona Z6
- Generic name
- Low-intensity laser fat liquefaction system, mobile
- Model / Ref / Catalog
- SHR
- Primary DI / UDI-DI
- 00858985006124
- 510(k) Number
- FDA product code
- OLI
- GMDN term
- Low-intensity laser fat liquefaction system, mobile
- Device class
- Class II
- Regulation number
- 878.5400
- GUDID distribution status
- In Commercial Distribution
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