# K083179: Mediled Phototherapy Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Medix I.C.S.A.
- Decided: Feb 27, 2009 after 122 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: 2 generations back to K940996 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite 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.

## Most influential descendants
- K103735: Mediled Mini (2011), 1 descendant of its own
- K160745: neoBLUE compact LED Phototherapy System (2016), 0 descendants of its own

## Indications for use
The MediLED Phototherapy Lamp is intended for the treatment for neonatal hyperbilirubinemia. The device is intended for use by healthcare professionals in a clinical setting.

Source page: https://510kreport.com/device/K083179
Methodology: https://510kreport.com/methodology