# K073689: LEP2000 Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Instruments, Inc.
- Decided: Nov 13, 2008 after 321 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The LEP2000 Photonic Therapy System is a device that emits energy in the infrared spectrum and is indicated for adjunctive use in providing temporary relief joint pain.

Source page: https://510kreport.com/device/K073689
Methodology: https://510kreport.com/methodology