Data / Medical devices / United States / Photonicare Inc
Photonicare Inc: FDA-registered device maker in Durham, NC, United States, 2 510(k) clearances
Photonicare Inc is registered with the FDA (registration 3016597890) in Durham, NC, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016597890
- Address
- 2800 Meridian Pkwy Ste 175, Durham, NC, United States, 27713
- Owner or operator
- PhotoniCare Inc (10062812)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer
- First device listed
- March 9, 2020
- Registered through
- 2026
- Brand names listed
- OtoSight Middle Ear Scope, TOMi Scope
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device System, Imaging, Tympanic Membrane And Middle Ear | QJG | 2 | Complaint file establishment, Manufacturer, Remanufacturer | 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 26, 2022 | K222655 | OtoSight Middle Ear Scope | QJG | Substantially Equivalent | Photonicare, Inc. | accessdata.fda.gov |
| December 5, 2019 | K191804 | TOMi Scope | QJG | Substantially Equivalent | Photonicare, Inc. | accessdata.fda.gov |
Updated September 26, 2022. 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.