# K042532: Biocare Systems Premir 818

- Pathway: 510(k) (Traditional)
- Applicant: Biocare Systems, Inc.
- Decided: Dec 13, 2004 after 87 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: 2 generations back to K974468 (1998). 5 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022888: Acubeam, Super Nova, Dio, Light Force Therapy, Inc. (2002) Summary page 1.
- K001179: Super Nova, Acubeam, Light Force Therapy, Inc. (2000)
- K032229: Quantum Warp 10 Light Delivery System, Quantum Devices, Inc. (2003) Summary page 1.

## Most influential descendants
- K051816: Lumiwave 1X4 Infrared Therapy Device (2005), 3 descendants of its own
- K051681: Dermillume Red, Model HR1000 (2005), 3 descendants of its own
- K081570: DPL Therapy System (2008), 1 descendant of its own
- K170068: Softcure 96 (2017), 0 descendants of its own
- K150554: NuBrilliance Light Pain Therapy (2015), 0 descendants of its own

## Indications for use
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief/ reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.

Source page: https://510kreport.com/device/K042532
Methodology: https://510kreport.com/methodology