Data / Medical devices / United States / Carewear Corp.
Carewear Corp.: FDA-registered device maker in Reno, NV, United States, 1 510(k) clearance
Carewear Corp. is registered with the FDA (registration 3014545271) in Reno, NV, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014545271
- Address
- 50 S Virginia St Ste 204, Reno, NV, United States, 89501
- Owner or operator
- Carewear Corp. (10057696)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 15, 2018
- Registered through
- 2026
- Brand names listed
- Carewear Firefly Controller, Carewear Firefly Lamps, Carewear Pain Relief and Recovery Light Therapy, Carewear Red Light Therapy, Carewear Wrinkle Reduction, Carewear Wrinkle Reduction System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | 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 |
|---|---|---|---|---|---|---|
| November 19, 2020 | K202442 | Carewear Firefly Wrinkle Reduction | OHS | Substantially Equivalent | Carewear Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Light Based Over The Counter Wrinkle Reduction
Updated November 19, 2020. 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.