Skip to content

Celestial Star CS2050C-MRI-UK

by Sunnex, Inc.

Celestial Star CS2050C-MRI-UK is a fixed examination/treatment room light (FDA Class I; FDA product code KZF, Device, medical examination, ac powered) made by Sunnex, Inc., cleared under FDA 510(k) K930711 on 30 Jul 1993 and listed in FDA GUDID since 3 Jan 2019 (UDI-DI 00853538008600), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K930711

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00853538008600 UDI-DI Date3 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK930711 Date30 Jul 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K930711 decided 30 Jul 1993 Active
  • FDA GUDID UDI-DI 00853538008600 listed 3 Jan 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-1101-2007 FDA Unclassified (pre-2012) initiated 13 Feb 2007 on shared 510(k) K930711

    Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K930711
  2. Recall initiated FDA recalls Z-1101-2007
  3. Listed FDA GUDID 00853538008600

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Celestial Star
Generic name
Fixed examination/treatment room light
Model / Ref / Catalog
CS2050C-MRI-UK
Primary DI / UDI-DI
00853538008600
510(k) Number
FDA product code
KZF
GMDN term
Fixed examination/treatment room light
Device class
Class I
Regulation number
880.6320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fixed examination/treatment room light

Similar devices in this category

Other devices filed under Fixed examination/treatment room light.

Other devices from Sunnex, Inc.

See all devices from Sunnex, Inc. →

Properties

  • Serial number
Other properties (14, all answered No)