Data / Medical devices / United States / Fiberoptic Fabrications
Fiberoptic Fabrications: FDA-registered device maker in Wilbraham, MA, United States, 1 510(k) clearance
Fiberoptic Fabrications is registered with the FDA (registration 3000313549) in Wilbraham, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 28, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000313549
- Address
- 495 Main St, Wilbraham, MA, United States, 01095
- Owner or operator
- Fiberoptic Fabrications (10042860)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 7, 2013
- Registered through
- 2026
- Brand names listed
- LithoWise, SideWise
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 28, 2012 | K120810 | FIBEROPTIC LASER DELIVERY SYSTEM | GEX | Substantially Equivalent | Fiberoptic Fabrications, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 28, 2012. 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.