CloudCover Plus NL-SK-8S
by Neolight LLC
CloudCover Plus NL-SK-8S is a blanket/pad infant phototherapy unit (FDA Class II; FDA product code LBI, Unit, Neonatal Phototherapy) made by Neolight LLC, cleared under FDA 510(k) K170585 on 27 Oct 2017 and listed in FDA GUDID since 11 Nov 2020 (UDI-DI 10852788008047), 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 | Number10852788008047 | Date11 Nov 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170585 | Date27 Oct 2017 | StatusActive |
Official records
- AccessGUDID record 10852788008047
- FDA 510(k) database K170585
Across registries
- FDA 510(k) K170585 decided 27 Oct 2017 Active
- FDA GUDID UDI-DI 10852788008047 listed 11 Nov 2020 Listed
Timeline
- Cleared FDA 510(k) K170585
- Listed FDA GUDID 10852788008047
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CloudCover Plus
- Generic name
- Blanket/pad infant phototherapy unit
- Model / Ref / Catalog
- NL-SK-8S
- Primary DI / UDI-DI
- 10852788008047
- 510(k) Number
- FDA product code
- LBI
- GMDN term
- Blanket/pad infant phototherapy unit
- Device class
- Class II
- Regulation number
- 880.5700
- GUDID distribution status
- In Commercial Distribution