510(k) Report

FDA applicant

Biodermis Corp.

Las Vegas, NV5 decisions1994–20010 recalls

FDA records 5 decisions for Biodermis Corp. (Las Vegas, NV) from 1994 to 2001: 5 510(k) clearances. Most are in product codes MDA (Elastomer, Silicone, For Scar Management) and GEH (Unit, Cryosurgical, Accessories). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Biodermis Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biodermis Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biodermis Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MDAElastomer, Silicone, For Scar Management4decisions
  • GEHUnit, Cryosurgical, Accessories1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K003948Epi-Derm Silicone Gel SheetingBiodermis Corp. · 20012cite it

What has FDA decided for it lately?

  • K003948Epi-Derm Silicone Gel SheetingBiodermis Corp. · 2001
  • K992146Scaraid Silicone Gel SheetingBiodermis Corp. · 1999
  • K991604Epi-Foam Silicone SheetingBiodermis Corp. · 1999
  • K964047Cryosil Silicone Gel SheetingBiodermis Corp. · 1997
  • K942156Epi-Derm Silicone Gel SheetingBiodermis Corp. · 1994

All 5 as Biodermis Corp. →