Leo Minor
by Sunnex, Inc.
510(k) K142984
Leo Minor is a medical device (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, 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 | FDA 510(k)SESE | NumberK142984 | Date29 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K142984
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FSY
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4580
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K142984
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Leo Minor LMI-300 | LMI-300 / LMI-300 | 00853538008365 | — | On the market |
| Leo Minor LMI-400 | LMI-400 / LMI-400 | 00853538008372 | — | On the market |
| Leo Minor LMI-400-AU | LMI-400-AU / LMI-400-AU | 00853538008570 | — | On the market |
| Leo Minor LMI-400-UK | LMI-400-UK / LMI-400-UK | 00853538008549 | — | On the market |
| Leo Minor LMI-550 | LMI-550 / LMI-550 | 00853538008389 | — | On the market |
| Leo Minor LMI-550-AU | LMI-550-AU / LMI-550-AU | 00853538008587 | — | On the market |
| Leo Minor LMI-700 | LMI-700 / LMI-700 | 00853538008396 | — | On the market |
| Leo Minor LMI-700-AU | LMI-700-AU / LMI-700-AU | 00853538008631 | — | On the market |
| Leo Minor LMI-700-EU | LMI-700-EU / LMI-700-EU | 00853538008624 | — | On the market |
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