Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2950792

FEI Number

1000135565

Entity Name

BIODERMIS LLC

City/State/Country

Henderson, NV, US

Establishment Address

1820 Whitney Mesa Dr, Suite 100, Henderson, NV 89014, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIODERMIS (Owner Number: 9015799)

Owner / Operator Contact Address

1820 Whitney Mesa Drive, Suite 100, Henderson, NV 89014, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K991604

PMA Number

N/A

All Registered Proprietary Names

Topigel Silicone Gel Sheeting DermaSof Silicone Gel Sheeting Epi-Derm Silicone Gel Sheeting Xeragel Silicone Gel Ointment Pro-Sil Silicone Stick Biocorneum Silisilk ScarAid Silicone Gel Sheeting Epi-Foam Silicone Backed Foam Pads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2013-10-31
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2003-01-28
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2013-10-30
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2013-10-30

Official Correspondent

Simone Depina

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIODERMIS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2950792. Last updated year: 2026. Please use registration number 2950792 when referencing this establishment in official correspondence.