Model note · Phototherapy Unit
Draeger BiliLux LED Phototherapy Light
BiliLux is an overhead LED phototherapy light for neonatal unconjugated hyperbilirubinaemia in babies up to 3 months and under 10 kg. Twenty blue LEDs deliver 460 to 490 nm light at five intensity levels, and two white LEDs give an examination light. It sits on an incubator hood or on a spring arm and trolley, and an optional radiometer checks irradiance.
The model
Maker, model and type.
- Maker
- Draeger Medical Systems, Inc.
- Model
- BiliLux LED Phototherapy Light
- Device type
- Phototherapy Unit
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Light sources | 20 blue LEDs (460 to 490 nm) for therapy plus 2 white LEDs for observation | Source |
| Irradiance at 100% setting | Above 85.5 uW/cm2/nm at 30 cm, 50.1 at 40 cm, 33.4 at 50 cm (460 to 490 nm) | Source |
| Intensity settings | 20, 40, 60, 80 and 100% of nominal | Source |
| Lifetime | Device service life 8 years; LED life 50,000 hours; running time counter fitted | Source |
| Size and weight | Light 39 x 19 x 8 cm, 1.2 kg; spring arm 1.5 kg; trolley 14.9 kg | Source |
| Electrical | 100 to 240 VAC, 50/60 Hz, 0.42 to 0.22 A; earth leakage under 500 uA | Source |
| Operating conditions | 18 to 40 C, 700 to 1100 hPa, 10 to 95% RH; noise 20 dB | Source |
| Standards and clearance | IEC 60601-1, 60601-1-2, 60601-2-50; K172656 (May 2018), predicate NanoBlu 500 (K113206); product code LBI, Class II | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Only for babies up to 3 months old and under 10 kg, under healthcare professional supervision. Source
- A light falling from its mount onto an incubator or infant is the main reported hazard, so secure mounting matters. Source
- Irradiance drops sharply with distance (85.5 at 30 cm to 33.4 at 50 cm), so moving the light changes the dose. Source
Sources
Where this note comes from.
- FDA 510(k) K172656 summary, Draeger BiliLux Phototherapy Light
- openFDA recall search, Draeger phototherapy (LBI)
- openFDA MAUDE problem counts, BiliLux brand
Not covered: Draeger's website and IFU refused automated access, so no error messages, cleaning agents or part details are included. The only Draeger phototherapy recall in openFDA covers the older PT 4000, not BiliLux. The summary prints irradiance in W/cm2/nm, which is taken here as microwatts per cm2 per nm, the usual unit; a reviewer should confirm.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Phototherapy Unit
Other models of this device.
Next