# K132163: Moorldls-BI Laser Doppler Burns Imager

- Pathway: 510(k) (Traditional)
- Applicant: Moor Instruments, Ltd.
- Decided: Jan 29, 2014 after 201 days
- Product code: DPT (Probe, Blood-Flow, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K905232 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060976: MOORLD12-B1 Laser Doppler Burns Imager, Moor Instruments, Ltd. (2007) Summary page 1.

## Indications for use
The moorLDLS-BI laser Doppler burns imager assesses the blood flow in burn wounds of skin, when cleaned of surface debris, to aid in the clinician's assessment of burn wound potential. It is intended to be used as an aid to burn wound management for patients with Body Surface Area burn of up to 30%.

Source page: https://510kreport.com/device/K132163
Methodology: https://510kreport.com/methodology