Data / Medical devices / United States / R2 Technologies, Inc.
R2 Technologies, Inc.: FDA-registered device maker in Dublin, CA, United States, 1 510(k) clearance
R2 Technologies, Inc. is registered with the FDA (registration 3025034781) in Dublin, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 10, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025034781
- Address
- 6517 Sierra Lane, Dublin, CA, United States, 94568
- Owner or operator
- R2 Technologies, Inc. (10054762)
- Roles
- Manufacturer
- First device listed
- November 17, 2022
- Registered through
- 2026
- Brand names listed
- Dermal Cooling System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | GED | 1 | Manufacturer | accessdata.fda.gov |
| Contact Cooling For Skin Lesion Pain Relief | QPZ | 2 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 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 |
|---|---|---|---|---|---|---|
| November 10, 2022 | K213294 | Dermal Cooling System | QPZ | Substantially Equivalent | R2 Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Contact Cooling For Skin Lesion Pain Relief
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Brush, Dermabrasion, Manual
Updated November 10, 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.