# K103735: Mediled Mini

- Pathway: 510(k) (Traditional)
- Applicant: Medix I.C.S.A.
- Decided: Aug 15, 2011 after 236 days
- Product code: LBI (Unit, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940996 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022196: Natus Blue Light Phototherapy Unit, Natus Medical, Inc. (2002) Summary page 1.
- K083179: Mediled Phototherapy Lamp, Medix I.C.S.A. (2009) Summary page 1.

## Most influential descendants
- K160745: neoBLUE compact LED Phototherapy System (2016), 0 descendants of its own

## Indications for use
The Medix MediLEDmini Phototherapy Lamp is intended for the treatment of neonatal hyperbilirubinemia. The device can be used with infants in a bassinet, incubator, open bed or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.

Source page: https://510kreport.com/device/K103735
Methodology: https://510kreport.com/methodology