# K032231: MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser

- Pathway: 510(k) (Traditional)
- Applicant: Medx Electronics, Inc.
- Decided: Oct 3, 2003 after 74 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 K001179 (2000). 2 ancestors in all.
74 later devices descend from it; 3 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020017: Medx 1000 Series, Medx Electronics, Inc. (2002) Summary page 2.

## Most influential descendants
- K082707: Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable Laser (2008), 59 descendants of its own
- K083595: Ezlase (2009), 58 descendants of its own
- K121286: EPIC 10 (2012), 31 descendants of its own
- K123971: Cynosure 1064NM Diode Laser (2013), 25 descendants of its own
- K170500: SIROLaser Advance+ (2017), 21 descendants of its own

## Indications for use
The MedX 1100 Console and MedX LCT 100 (785 nm) and Duolight 100 (785 run) & 500 Accessories are an infrared lamp system, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis. The MedX LCS 100 Portable Laser (785 nm) is an infrared lamp, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

Source page: https://510kreport.com/device/K032231
Methodology: https://510kreport.com/methodology