# K052934: Dermosonic Non-Invasive Subdermal Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: S.O.R. Internacional, S.A.
- Decided: Jun 12, 2006 after 236 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K024307 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024307: Dermosonic Non-Invasive Subdermal Therapy System, Sybaritic, Inc. (2003) Summary page 2.

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

Source page: https://510kreport.com/device/K052934
Methodology: https://510kreport.com/methodology