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Cloud Swaddle NL-SK-5

by Neolight LLC

Cloud Swaddle NL-SK-5, a blanket/pad infant phototherapy unit (FDA Class II; FDA product code LBI, Unit, Neonatal Phototherapy) made by Neolight LLC, was cleared under FDA 510(k) K170585 on 27 Oct 2017 and listed in FDA GUDID on 9 Nov 2018 (UDI-DI 10852788008092); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K170585

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10852788008092 UDI-DI Date9 Nov 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170585 Date27 Oct 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170585 decided 27 Oct 2017 Active
  • FDA GUDID UDI-DI 10852788008092 listed 9 Nov 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170585
  2. Listed FDA GUDID 10852788008092

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cloud Swaddle
Generic name
Blanket/pad infant phototherapy unit
Model / reference
NL-SK-5
Primary DI / UDI-DI
10852788008092
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
Not in Commercial Distribution

Related devices

Cleared under the same submission (K170585)

and 4 more cleared under K170585

Similar devices

Other devices filed under FDA product code LBI (Unit, Neonatal Phototherapy).

Other devices from Neolight LLC

See all devices from Neolight LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)