# K221189: Oliz LTB-1000A

- Pathway: 510(k) (Traditional)
- Applicant: Ltbio Co., Ltd.
- Decided: Aug 29, 2022 after 126 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- 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
Longest line of descent: 14 generations back to K943450 (1995). 135 ancestors in all.
No later device cites it as a predicate yet.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152280: BioPhotas Celluma3, Biophotas, Inc. (2016) Summary page 5.

## Indications for use
The OLIZ LTB-1OOOA is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K221189
Methodology: https://510kreport.com/methodology