510(k) Report

FDA applicant

Sybaritic, Inc.

Bloomington, MN1 decision2003–20031 recall

FDA records 1 decision for Sybaritic, Inc. (Bloomington, MN) in 2003: 1 510(k) clearance. All are in product code IMI (Ultrasonic Diathermy For Use In Applying…). 1 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Sybaritic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sybaritic, Inc. 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?

  • IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat1decision

Who builds on its devices?

Later devices cite its devices 5 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.

  • K024307Dermosonic Non-Invasive Subdermal Therapy SystemSybaritic, Inc. · 20035cite it

What has FDA decided for it lately?

  • K024307Dermosonic Non-Invasive Subdermal Therapy SystemSybaritic, Inc. · 20031 recall

The one decision as Sybaritic, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K024307Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy SystemJan 5, 2005