← Product Code [OHV](/submissions/SU/subpart-e%E2%80%94surgical-devices/OHV) · K231537

# SofWave System (K231537)

_Sofwave Medical, Ltd. · OHV · Aug 28, 2023 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHV/K231537

## Device Facts

- **Applicant:** Sofwave Medical, Ltd.
- **Product Code:** [OHV](/submissions/SU/subpart-e%E2%80%94surgical-devices/OHV.md)
- **Decision Date:** Aug 28, 2023
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4590
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHV/K231537](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHV/K231537)

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