Data / Medical devices / United States / Nuance Medical, LLC
Nuance Medical, LLC: FDA-registered device maker in Las Vegas, NV, United States, 4 510(k) clearances
Nuance Medical, LLC is registered with the FDA (registration 2950792) in Las Vegas, NV, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated January 29, 2001. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2950792
- FEI number
- 1000135565
- Address
- 4120 W. Windmill Ln Suite 101, Las Vegas, NV, United States, 89139
- Owner or operator
- Nuance Medical LLC (9015799)
- Roles
- Manufacturer
- First device listed
- January 28, 2003
- Registered through
- 2027
- Brand names listed
- Biocorneum Silisilk, DermaSof Silicone Gel Sheeting, Epi-Derm Silicone Gel Sheeting, Epi-Foam Silicone Backed Foam Pads, Pro-Sil Silicone Stick, ScarAid Silicone Gel Sheeting, Topigel Silicone Gel Sheeting, Xeragel Silicone Gel Ointment
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Elastomer, Silicone, For Scar Management | MDA | 1 | 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 |
|---|---|---|---|---|---|---|
| January 29, 2001 | K003948 | EPI-DERM SILICONE GEL SHEETING | MDA | Substantially Equivalent | Biodermis Corp. | accessdata.fda.gov |
| July 30, 1999 | K992146 | SCARAID SILICONE GEL SHEETING | MDA | Substantially Equivalent | Biodermis Corp. | accessdata.fda.gov |
| June 9, 1999 | K991604 | EPI-FOAM SILICONE SHEETING | MDA | Substantially Equivalent | Biodermis Corp. | accessdata.fda.gov |
| September 30, 1991 | K913140 | SILICONE GEL SHEETING | MDA | Substantially Equivalent | Cui Corp. | accessdata.fda.gov |
Compare with other makers
Updated January 29, 2001. 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.