# K971256: Duo-Lite Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Air-Shields, Inc.
- Decided: Sep 24, 1997 after 173 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Air-Shields Micro-Lite Phototherapy System: named in the summary without a submission number
- (no number) Air-Shields Fluoro-Lite Phototherapy Unit: named in the summary without a submission number
- (no number) Ohmeda Spot Phototherapy Lamp: named in the summary without a submission number
- (no number) Olympic 66: named in the summary without a submission number
- (no number) Olympic 33: named in the summary without a submission number
- (no number) Drager PT4000: named in the summary without a submission number

## Most influential descendants
- K021531: Rpi Replacement Phototherapy Lights (2002), 0 descendants of its own

## Indications for use
The DUO-LITE™ Phototherapy System is designed to provide treatment in the form of Phototherapy to those infants that have been identified as having elevated bilirubin levels (hyperbilirubinemia). Phototherapy as a means for reducing bilirubin levcls is a well established treatment modality. The output of the light has been optimized for maximum absorption by the skin in order to reduce the bilirubin levels as quickly as possible. The DUO-LITE™ Phototherapy System provides the option to select white or blue light via a selector switch. This provides the caregiver with the option to give high output phototherapy for some infants (or early in the treatment cycle) followed by more moderate phototherapy for other infants (or later in the treatment cycle). By contrast, other phototherapy lamp products give the option of either White or Blue light which needs to be set up by an engineer in advance of the treatment. The Duo-LITE™ has combined these two light sources into one housing for the convenience of the caregiver. The DuUo-LITE™ Phototherapy System can be placed on the hood of an infant incubator, mounted on the Air-Shields Rail System. or positioned over an open warming bed or crib.

Source page: https://510kreport.com/device/K971256
Methodology: https://510kreport.com/methodology