# Leo Minor LMI-550

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/leo-minor-lmi-550>
- Manufacturer: [Sunnex, Inc.](https://devicerts.com/manufacturers/sunnex-inc) (United States, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: FSY
- GMDN: Operating room light (12282)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00853538008389 · listed 2018-02-26 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K142984 · decision 2014-10-29 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: Leo Minor [FDA GUDID (AccessGUDID)]
- Generic name: Operating room light [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: LMI-550 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00853538008389 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K142984 [FDA GUDID (AccessGUDID)]
- FDA product code: FSY [FDA GUDID (AccessGUDID)]
- GMDN term: Operating room light (12282) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4580 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Leo Minor LMI-550, Sunnex, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/leo-minor-lmi-550 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/leo-minor-lmi-550.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/leo-minor-lmi-550
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.