# K023621: Bioflex Professional Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Meditech International, Inc.
- Decided: Apr 10, 2003 after 163 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: 1 generation back to K001179 (2000). 1 ancestor in all.
311 later devices descend from it; 8 cite it directly.
0 of 313 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001179: Super Nova, Acubeam, Light Force Therapy, Inc. (2000)

## Most influential descendants
- K033768: Altus Medical Optional Infrared Handpiece (2004), 294 descendants of its own
- K042165: Cutera Tabletop Aesthetic Product (2004), 241 descendants of its own
- K050370: Palomar Luxir Handpiece (2005), 239 descendants of its own
- K080318: Alma Laser Nir Module (2008), 184 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own

## Indications for use
The BioFfex tm Professional Therapy System is used by trained health care professionals and is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue. The BioFCex im Professional Therapy System is a “multi-mode” Low Level Light treatment system configured for multiple treatment heads powered by a flexible protocol controller that delivers various treatment protocols.

Source page: https://510kreport.com/device/K023621
Methodology: https://510kreport.com/methodology