BWF-5 Medical Laser Series
FDA 510(k)Class II (US FDA 510(k))
by Litecure Llc
Identifiers
- 510(k) Number
- K123031 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 BWF-5 Medical Laser Series is a powered laser surgical instrument designed for the delivery of laser light to soft tissue. It operates at multiple wavelengths (810nm, 930nm, 980nm, 1080nm, and 1320nm) and can be used in both contact and non-contact modes, including through endoscopic, introducer, or catheter-based applications.
This device is supplied as a reusable medical instrument and is intended for use in surgical settings. It has received FDA 510(k) clearance under the General & Plastic Surgery advisory committee, with a classification under product code GEX. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What types of surgical procedures can the BWF-5 Medical Laser Series be used for, and how does it differ in application between contact and non-contact modes?
The BWF-5 Medical Laser Series is designed for soft tissue surgical procedures and can be applied in both contact and non-contact modes. The contact mode allows direct application of laser light to tissue, while non-contact modes—such as endoscopic, introducer, or catheter-based delivery—enable precision in minimally invasive surgeries. Its multiple wavelengths (810nm, 930nm, 980nm, 1080nm, and 1320nm) provide flexibility for different tissue interactions, though the exact clinical applications depend on the surgeon’s technique and the specific wavelength chosen.
Is the BWF-5 Medical Laser Series intended for single-use or reusable applications, and what does this mean for maintenance and sterilization?
The BWF-5 Medical Laser Series is explicitly described as a reusable medical instrument. This means it is designed for repeated use in surgical settings, requiring proper cleaning, maintenance, and sterilization between procedures to ensure safety and functionality. Since no specific sterility instructions are provided in the data, users should follow manufacturer guidelines (from Litecure LLC) for reprocessing to comply with regulatory and clinical standards.
What regulatory pathway was followed for FDA clearance of the BWF-5 Medical Laser Series, and how does this classification impact its use?
The BWF-5 Medical Laser Series received FDA clearance through a 510(k) submission, classified as substantially equivalent under the General & Plastic Surgery advisory committee (product code GEX). This means the device was evaluated against a predicate (a legally marketed device) and determined to have similar intended use and technological characteristics. Clinically, this classification does not restrict its use to specific procedures but confirms its compliance with FDA standards for laser surgical instruments in soft tissue applications.
How are the different wavelengths (810nm, 930nm, 980nm, 1080nm, and 1320nm) of the BWF-5 Medical Laser Series intended to be utilized in surgical settings?
The BWF-5’s multiple wavelengths (810nm through 1320nm) are likely tailored to interact differently with tissue types, enabling varied effects such as coagulation, vaporization, or photothermal therapy. For example, lower wavelengths (e.g., 810nm) may penetrate less deeply and are often used for surface-level procedures, while higher wavelengths (e.g., 1320nm) might offer deeper tissue interaction. The exact clinical applications depend on the surgeon’s selection of wavelength, power settings, and delivery mode (contact/non-contact) to achieve the desired outcome.
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: BWF-5 MEDICAL LASER SERIES (K093087) — FDA 510(k) | Innolitics, BWF-5 MEDICAL LASER SERIES (K123031) — FDA 510(k) | Innolitics, BWF-5 MEDICAL LASER SERIES 510(k) K093087 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123031 | Class II | Active |
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Manufacturer
- Manufacturer
- Litecure Llc
- FDA Applicant
- Litecure, LLC
Sources (1)
- FDA 510(k) K123031 24 fields · synced Sep 19, 2026