Data / Medical devices / United States / NIRA Innovations Inc
NIRA Innovations Inc: FDA-registered device maker in Derry, NH, United States, 2 510(k) clearances
NIRA Innovations Inc is registered with the FDA (registration 3015109022) in Derry, NH, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 8, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015109022
- Address
- 42 Nh 111, Derry, NH, United States, 03038
- Owner or operator
- NIRA Innovations Inc (10059230)
- Roles
- Manufacturer
- First device listed
- December 13, 2018
- Registered through
- 2026
- Brand names listed
- NIRA, NIRA PRO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | 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 |
|---|---|---|---|---|---|---|
| February 8, 2023 | K222685 | NIRA Model 2 | OHS | Substantially Equivalent | Dermal Photonics Corp | accessdata.fda.gov |
| July 12, 2017 | K163137 | NIRA Beauty Skin Laser | OHS | Substantially Equivalent | Dermal Photonics Corporation | accessdata.fda.gov |
Compare with other makers
Updated February 8, 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.