Zye Alx 25704
Zye Alx 25704 is a Class II device made by Vydence Medical, cleared under FDA 510(k) K190007 on 1 Mar 2019 and listed in FDA GUDID since 27 May 2024 (UDI-DI 07898961835211), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07898961835211 | Date27 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190007 | Date1 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 07898961835211
- FDA 510(k) database K190007
Across registries
- FDA 510(k) K190007 decided 1 Mar 2019 Active
- FDA GUDID UDI-DI 07898961835211 listed 27 May 2024 Listed
Timeline
- Cleared FDA 510(k) K190007
- Listed FDA GUDID 07898961835211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zye Alx
- Generic name
- Multi-modality skin surface treatment system
- Model / Ref / Catalog
- 25704
- Primary DI / UDI-DI
- 07898961835211
- 510(k) Number
- FDA product code
- GEX, ONF, PDZ
- GMDN term
- Multi-modality skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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