Data / Medical devices / United States / InnoVoyce LLC
InnoVoyce LLC: FDA-registered device maker in Boston, MA, United States, 2 510(k) clearances
InnoVoyce LLC is registered with the FDA (registration 3024753061) in Boston, MA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024753061
- Address
- One Beacon St Floor 15, Boston, MA, United States, 02108
- Owner or operator
- InnoVoyce (10062599)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 19, 2023
- Registered through
- 2026
- Brand names listed
- InnoVoyce Laser Fiber, InnoVoyce VYLO Laser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| May 29, 2024 | K240159 | InnoVoyce VYLO | GEX | Substantially Equivalent | Innovoyce | accessdata.fda.gov |
| May 25, 2022 | K220793 | InnoVoyce Laser Fiber | GEX | Substantially Equivalent | Innovoyce, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 29, 2024. 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.