Data / Medical devices / United States / Phoenix Technology Group LLC
Phoenix Technology Group LLC: FDA-registered device maker in Pleasanton, CA, United States, 2 510(k) clearances
Phoenix Technology Group LLC is registered with the FDA (registration 3012096560) in Pleasanton, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012096560
- Address
- 6630 Owens DR, Pleasanton, CA, United States, 94588
- Owner or operator
- NeoLight, LLC (10056250)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 7, 2022
- Registered through
- 2026
- Brand names listed
- Connect, ICON Connect, ICON Cart, ICON GO, ICON Handpiece Disinfection Station, Phoenix ICON, ICON, ICON Cart, Phoenix ICON, ICON, ICON Cart, Phoenix ICON GO, ICON GO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Camera, Ophthalmic, General-Use | PJZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Communications, Images, Ophthalmic | NFG | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 6, 2023 | K223575 | Phoenix ICON, Phoenix ICON GO | HKI | Substantially Equivalent | Neolight, LLC | accessdata.fda.gov |
| September 15, 2017 | K170527 | Phoenix Clinical ICON | HKI | Substantially Equivalent | Phoenix Technology Group, Inc. Dba Phoenix Clinical | accessdata.fda.gov |
Compare with other makers
- All makers of Camera, Ophthalmic, Ac-Powered
- All makers of Camera, Ophthalmic, General-Use
- All makers of Device, Communications, Images, Ophthalmic
Updated September 6, 2023. 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.