Leo Minor LMI-300

by Sunnex, Inc.

Leo Minor LMI-300 is a mobile examination/treatment 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 00853538008365), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00853538008365 UDI-DI	Date26 Feb 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK142984	Date29 Oct 2014Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00853538008365
FDA 510(k) database 510(k) number K142984

Across registries

2 registries list this device

FDA 510(k) K142984 decided 29 Oct 2014 Active
FDA GUDID UDI-DI 00853538008365 listed 26 Feb 2018 Listed

Timeline

2 dated events

29 Oct 2014 Cleared FDA 510(k) K142984
26 Feb 2018 Listed FDA GUDID 00853538008365

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Leo Minor
Generic name: Mobile examination/treatment room light
Model / Ref / Catalog: LMI-300

Primary DI / UDI-DI: 00853538008365
510(k) Number: K142984
FDA product code: FSY
GMDN term: Mobile examination/treatment room light

Device class: Class II
Regulation number: 878.4580
GUDID distribution status: In Commercial Distribution

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Properties

Serial number

Other properties (14, all answered No)