# K030295: Ltu-904 Portable Laser Therapy Unit

- Pathway: 510(k) (Traditional)
- Applicant: Riancorp Pty, Ltd.
- Decided: Dec 23, 2004 after 695 days
- Product code: NZY (Light, Lymphedema Reduction, Low Energy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) MicroLight Corporation of America’s MicroLight 830: named in the summary without a submission number
- (no number) Acculaser, Inc.’s Acculaser Pro Low Level Laser Therapy: named in the summary without a submission number

## Indications for use
The LTU-904 is indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.

Source page: https://510kreport.com/device/K030295
Methodology: https://510kreport.com/methodology