Sunoptic Technologies Halogen Lightsources
Sunoptic Technologies Halogen Lightsources is a Class II device made by Sunoptic Technologies, cleared under FDA 510(k) K980166 on 1 Apr 1998 and listed in FDA GUDID since 5 May 2017 (UDI-DI M678HAL0), 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 | NumberM678HAL0 | Date5 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK980166 | Date1 Apr 1998 | StatusActive |
Official records
- FDA 510(k) database K980166
Across registries
- FDA 510(k) K980166 decided 1 Apr 1998 Active
- FDA GUDID UDI-DI M678HAL0 listed 5 May 2017 Listed
Timeline
- Cleared FDA 510(k) K980166
- Listed FDA GUDID M678HAL0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sunoptic Technologies
- Generic name
- General-purpose light source
- Model / reference
- Halogen Lightsources
- Primary DI / UDI-DI
- M678HAL0
- 510(k) Number
- FDA product code
- FCW
- GMDN term
- General-purpose light source
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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