# K041885: Bioflex LD-175 and LD-1200 Treatment Heads

- Pathway: 510(k) (Traditional)
- Applicant: Meditech International, Inc.
- Decided: Feb 24, 2005 after 227 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: 4 generations back to K871179 (1987). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033768: Altus Medical Optional Infrared Handpiece, Altus Medical, Inc. (2004) Summary page 2.
- K031612: Alt Laser, Model VTR 75, Avicenna Laser Technology, Inc. (2003) Summary page 2.
- K024179: Palomar Lightcube, Palomar Medical Products, Inc. (2003) Summary page 2.

## Most influential descendants
- K051875: Bioflex Prescription System and Related Treatment Heads (2006), 1 descendant of its own
- K081355: Bioflex LD-R100 Treatment Head (2008), 0 descendants of its own

## Indications for use
The BioFlex s LD-I75 & LD-I200 Treatment Heads are intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

Source page: https://510kreport.com/device/K041885
Methodology: https://510kreport.com/methodology