# K173067: LightForce LTS Model 1000, 1500, 2500, and 4000

- Pathway: 510(k) (Traditional)
- Applicant: Litecure, LLC
- Decided: Feb 22, 2018 after 146 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 460 ancestors in all.
No later device cites it as a predicate yet.
0 of 461 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070516: Powerlaser, Powermedic Aps (2007) Summary page 4.
- K151890: Medical Diode Laser Systems, Wuhan Gigaa Optronics Technology Co., Ltd. (2015) Summary page 4.
- K123014: Litecure Therapy System Model LTS-1500, Litecure, LLC (2013) Summary page 4.

## Indications for use
810 nm and 980 nm wavelength: The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. 980 nm wavelength: The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis. 980 nm wavelength: The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)

Source page: https://510kreport.com/device/K173067
Methodology: https://510kreport.com/methodology