BWF-5 Medical Laser Series
FDA 510(k)Class II (US FDA 510(k))
by Litecure Llc
Identifiers
- 510(k) Number
- K093087 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 in either contact or non-contact modes during surgical procedures, including those performed via endoscopes, introducers, or catheters.
This device is available in wavelengths of 810nm, 930nm, 980nm, 1080nm, and 1320nm. It has received FDA 510(k) clearance.
Frequently asked questions
What is the primary function of the BWF-5 Medical Laser Series?
The BWF-5 is a powered laser surgical instrument intended for the delivery of laser light to soft tissue. It is designed to support surgical procedures performed in both contact and non-contact modes, including those utilizing endoscopes, catheters, or introducers.
What wavelength options are available for this laser system?
The BWF-5 Medical Laser Series is available in five distinct wavelengths to accommodate different surgical requirements: 810nm, 930nm, 980nm, 1080nm, and 1320nm.
What is the regulatory status of the BWF-5 Medical Laser Series?
The BWF-5 Medical Laser Series has received FDA 510(k) clearance under the submission number K093087. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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 | K093087 | Class II | Active |
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Manufacturer
- Manufacturer
- Litecure Llc
- FDA Applicant
- Litecure, LLC
Sources (1)
- FDA 510(k) K093087 24 fields · synced Sep 24, 2026