# K170068: Softcure 96

- Pathway: 510(k) (Traditional)
- Applicant: Wellray Medical Laser, Inc.
- Decided: May 5, 2017 after 116 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: 13 generations back to K943450 (1995). 142 ancestors in all.
No later device cites it as a predicate yet.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051816: Lumiwave 1X4 Infrared Therapy Device, Biocare Systems, Inc. (2005) Summary page 4.
- K121920: Laserbrush, Sunetics International Marketing Group, LLC (2013) Summary page 4.
- K931261: Spectropad System, Smi (1994) Summary page 4.
- K131113: Biophotas Celluma, Biophotas, Inc. (2014) Summary page 4.

## Indications for use
The Softcure TM 96 is intended to emit energy in the visible spectrum (red 635nm) to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

Source page: https://510kreport.com/device/K170068
Methodology: https://510kreport.com/methodology