Data / Medical devices / United States / WEINERT Fiber Optics Inc.
WEINERT Fiber Optics Inc.: FDA-registered device maker in Williamsburg, VA, United States, 3 510(k) clearances
WEINERT Fiber Optics Inc. is registered with the FDA (registration 3007336385) in Williamsburg, VA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 30, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007336385
- Address
- 209 Bulifants Blvd, Williamsburg, VA, United States, 23188
- Owner or operator
- WEINERT Fiber Optics, Inc. (10085607)
- Roles
- Manufacturer
- First device listed
- July 8, 2022
- Registered through
- 2026
- Brand names listed
- Neulight®
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 30, 2021 | K211761 | UltraLase Flexible CO2 Laser Waveguide | GEX | Substantially Equivalent | W & R Investments, LLC Dba Laser Engineering | accessdata.fda.gov |
| April 2, 2021 | K201171 | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable | GEX | Substantially Equivalent | Leoni Fiber Optics, Inc. | accessdata.fda.gov |
| June 2, 2005 | K050738 | FT FIBER OPTIC DELIVERY SYSTEMS | GEX | Substantially Equivalent | Fibertech GmbH | accessdata.fda.gov |
Compare with other makers
Updated July 30, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.