Data / Medical devices / United States / Nuance Medical, LLC
Nuance Medical, LLC: FDA-registered device maker in Carlsbad, CA, United States, 4 510(k) clearances
Nuance Medical, LLC is registered with the FDA (registration 3010543854) in Carlsbad, CA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010543854
- Address
- 5931 Sea Lion Place Suite 113, Carlsbad, CA, United States, 92010
- Owner or operator
- Nuance Medical, LLC (10045112)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 21, 2013
- Registered through
- 2026
- Brand names listed
- Ear Wash Basin, Easentials Adhesive Remover Spray, Easentials Skin Barrier Spray, Hurri-Freeze, Pain Freeze II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Basin, Emesis | FNY | 1 | Manufacturer | accessdata.fda.gov |
| Collector, Ostomy | EXB | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 2 | Manufacturer | accessdata.fda.gov |
| Vapocoolant Device | MLY | U | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 12, 2024 | K232674 | PainFreeze II | MLY | Substantially Equivalent | Nuance Medical, LLC | accessdata.fda.gov |
| November 22, 2016 | K162218 | Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102 | MLY | Substantially Equivalent | Nuance Medical, LLC | accessdata.fda.gov |
| July 12, 2016 | K161337 | CryoDose H or Similar | GEH | Substantially Equivalent | Nuance Medical, LLC | accessdata.fda.gov |
| June 14, 2013 | K130995 | NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY | GEH | Substantially Equivalent | Nuance Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Vapocoolant Device
- All makers of Unit, Cryosurgical, Accessories
- All makers of Basin, Emesis
- All makers of Collector, Ostomy
Updated February 12, 2024. 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.