510(k) Report

FDA applicant

Silk*Skin Care Co.

Queensbury, NY1 decision1995–19950 recalls

FDA records 1 decision for Silk*Skin Care Co. (Queensbury, NY) in 1995: 1 510(k) clearance. All are in product code MDA (Elastomer, Silicone, For Scar Management). 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 Silk*Skin Care Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Silk*Skin Care Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Silk*Skin Care Co. 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 Management1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K953420Silk*Skin Scar TreatmentSilk*Skin Care Co. · 19951cites it

What has FDA decided for it lately?

  • K953420Silk*Skin Scar TreatmentSilk*Skin Care Co. · 1995

The one decision as Silk*Skin Care Co. →

Other applicant names beginning “Silk*Skin”

FDA records each applicant name separately; these may or may not be the same firm.

Silk Road Medical, Inc. 6Silk Holdings, Inc. 1Silk'N Beauty, Ltd. 1