# K024307: Dermosonic Non-Invasive Subdermal Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Sybaritic, Inc.
- Decided: Jul 2, 2003 after 190 days
- Product code: IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112520: US-101L, US-103S (2011), 4 descendants of its own
- K161628: JAS Pulse (TM) Ultrasonic Therapy (2016), 3 descendants of its own
- K053041: Med Sculpt (2006), 3 descendants of its own
- K241099: Plasonic (Plasonic) (2024), 2 descendants of its own
- K091615: Med Contour (2010), 2 descendants of its own

## Recalls of this device
- Jan 5, 2005 · Not classified · Z-0578-05: Device is performing functions that are not cleared in the 510(k).

## Indications for use
Indications for use include the following: a. Therapeutic Massager: 1. Provides temporary relief of minor muscle aches and pains 11. Relieves muscle spasms 111. Temporarily improves local blood circulation iv. Temporarily reduces the appearance of cellulite b. Ultrasonic Diathermy: i. Relief of pain 11. Muscle spasms iii. Joint contractures iv. NOT for the treatment of malignancies

Source page: https://510kreport.com/device/K024307
Methodology: https://510kreport.com/methodology