Nordlys System 9SYS7751-203
Nordlys System 9SYS7751-203 is a Class II device made by Candela Corporation, cleared under FDA 510(k) K212492 on 20 Dec 2021 (1 earlier submission) and listed in FDA GUDID since 20 May 2022 (UDI-DI 00817495023458), 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 | GUDID listing | Number00817495023458 | Date20 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212492 | Date20 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 00817495023458
- FDA 510(k) database K212492
- FDA 510(k) database K150907
Across registries
- FDA 510(k) K212492 decided 20 Dec 2021 Active
- FDA GUDID UDI-DI 00817495023458 listed 20 May 2022 Listed
Timeline
- Cleared FDA 510(k) K150907
- Cleared FDA 510(k) K212492
- Listed FDA GUDID 00817495023458
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nordlys System
- Generic name
- Multi-modality skin surface treatment system generator
- Model / reference
- 9SYS7751-203
- Primary DI / UDI-DI
- 00817495023458
- FDA product code
- GEX, ONF
- GMDN term
- Multi-modality skin surface treatment system generator
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution