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Leo Minor LMI-550

by Sunnex, Inc.

Leo Minor LMI-550 is an operating room light (FDA Class II; FDA product code FSY, Light, surgical, ceiling mounted) made by Sunnex, Inc., cleared under FDA 510(k) K142984 on 29 Oct 2014 and listed in FDA GUDID since 26 Feb 2018 (UDI-DI 00853538008389), 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 found

in data synced 22 Oct 2026

Documents

510(k) K142984

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 Number00853538008389 UDI-DI Date26 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142984 Date29 Oct 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142984 decided 29 Oct 2014 Active
  • FDA GUDID UDI-DI 00853538008389 listed 26 Feb 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142984
  2. Listed FDA GUDID 00853538008389

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Leo Minor
Generic name
Operating room light
Model / Ref / Catalog
LMI-550
Primary DI / UDI-DI
00853538008389
510(k) Number
FDA product code
FSY
GMDN term
Operating room light
Device class
Class II
Regulation number
878.4580
GUDID distribution status
In Commercial Distribution

Related devices

Category: Operating room light

Cleared under the same submission (K142984)

and 4 more cleared under K142984

Similar devices

Other devices filed under FDA product code FSY (Light, surgical, ceiling mounted).

Other devices from Sunnex, Inc.

See all devices from Sunnex, Inc. →

Properties

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