Leo Minor LMI-700
by Sunnex, Inc.
Leo Minor LMI-700 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 00853538008396), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00853538008396 | Date26 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142984 | Date29 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 00853538008396
- FDA 510(k) database K142984
Across registries
- FDA 510(k) K142984 decided 29 Oct 2014 Active
- FDA GUDID UDI-DI 00853538008396 listed 26 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K142984
- Listed FDA GUDID 00853538008396
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Leo Minor
- Generic name
- Operating room light
- Model / Ref / Catalog
- LMI-700
- Primary DI / UDI-DI
- 00853538008396
- 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
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