LightForce LTS Model 1000, 1500, 2500, and 4000
FDA 510(k)Class II (US FDA 510(k))
by Litecure Llc
Identifiers
- 510(k) Number
- K173067 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LightForce LTS Model 1000, 1500, 2500, and 4000 are diode laser systems with a console assembly that includes a touch-screen GUI and main processor PCA. Operators can select built-in treatment protocols or adjust optical output power and treatment times via the touch panel.
The device is supplied by LiteCure, LLC and is a Class 2 General & Plastic Surgery powered laser surgical instrument. It received FDA 510(k) clearance with number K173067 on 2018-02-22, having been determined substantially equivalent to predicate devices.
Frequently asked questions
What is the LightForce LTS laser system used for?
The LightForce LTS Model 1000, 1500, 2500, and 4000 are diode laser systems designed for general and plastic surgery procedures. They feature a touch-screen interface allowing operators to select built-in treatment protocols or adjust optical output power and treatment times.
How is the LightForce LTS laser system supplied?
The device is supplied by LiteCure, LLC as a Class 2 General & Plastic Surgery powered laser surgical instrument. It includes a console assembly with a touch-screen GUI and main processor PCA.
What regulatory clearance does the LightForce LTS have?
The LightForce LTS laser system received FDA 510(k) clearance with number K173067 on February 22, 2018. It was determined to be substantially equivalent to predicate devices for general and plastic surgery applications.
What models are available in the LightForce LTS series?
The LightForce LTS series includes four models: Model 1000, Model 1500, Model 2500, and Model 4000. Each model offers different specifications and capabilities while maintaining the same core functionality as a diode laser system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LightForce LTS Model 1000, 1500, 2500, and 4000 (K173067) — FDA 510(k ..., LightForce LTS Model 1000, 1500, 2500, And 4000… - FDA.report, K173067 FDA 510(k) - LightForce LTS Model 1000 | Litecure, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173067 | Class II | Active |
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Manufacturer
- Manufacturer
- Litecure Llc
- FDA Applicant
- Litecure, LLC
Sources (1)
- FDA 510(k) K173067 24 fields · synced Sep 27, 2026