DioBreeze FS80020
DioBreeze FS80020 is a Class II device made by Formatk Systems Ltd, cleared under FDA 510(k) K162781 on 9 Nov 2016 and listed in FDA GUDID since 25 Jun 2021 (UDI-DI 07290016681079), 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 | Number07290016681079 | Date25 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162781 | Date9 Nov 2016 | StatusActive |
Official records
- AccessGUDID record 07290016681079
- FDA 510(k) database K162781
Across registries
- FDA 510(k) K162781 decided 9 Nov 2016 Active
- FDA GUDID UDI-DI 07290016681079 listed 25 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K162781
- Listed FDA GUDID 07290016681079
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DioBreeze
- Generic name
- Dermatological diode laser system
- Model / Ref / Catalog
- FS80020
- Primary DI / UDI-DI
- 07290016681079
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological diode laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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