Manufacturer
Litecure, LLCLightForce LTS Model 1000, 1500, 2500, and 4000
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K173067
- Device name
- LightForce LTS Model 1000, 1500, 2500, and 4000
- Company
- Litecure, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-09-29
- Decision date
- 2018-02-22
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
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. 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.
Intended 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.
Device Description
The LightForce LTS Model 1000, 1500, 2500, and 4000 are diode laser devices that emit energy at wavelengths of 810 nm ± 20 nm and/or 980 nm ± 20 nm. They are designed for both therapeutic and surgical applications, providing topical heating and facilitating procedures such as hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue.
Summary parsed at:2026-06-01 05:56:27 UTC
Predicate devices
3—
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Not ingested
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Not ingested
Medical Diode Laser Systems
K173067 references 3 predicate/reference devices
Cited as predicate
1Aurolase Therapy, Laser Delivery Device (LDD)
1 submission cite K173067 as a predicate
