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Med Sculpt

by General Project S.R.L.

510(k) K053041

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK053041 Date2 Aug 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IMI
Device Class
Class II
Regulation
21 CFR Part 890.5300
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Med Sculpt Sonic is an Ultrasonic Diathermy Device designed for applying therapeutic deep heat. It combines elastomeric massage with ultrasound technology to facilitate non-invasive body contouring treatments by enhancing tissue movement and circulation through a patented elastomeric membrane with varying densities.

This device is supplied with a zonal massage plug-in handpiece and features a 10.4-inch touchscreen color display offering 75 preselected programs across four power levels. It is classified as a Class II medical device under FDA regulations (510(k) clearance, K053041) and is intended for use in physical medicine settings. The device is reusable and requires proper storage to maintain functionality.

Other devices from General Project S.R.L.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Med Sculpt Sonic device used for?

    The Med Sculpt Sonic is an Ultrasonic Diathermy Device designed for applying therapeutic deep heat and facilitating non-invasive body contouring treatments by enhancing tissue movement and circulation through a patented elastomeric membrane with varying densities.

  • What is included with the Med Sculpt Sonic device?

    The device is supplied with a zonal massage plug-in handpiece and features a 10.4-inch touchscreen color display offering 75 preselected programs across four power levels.

  • Is the Med Sculpt Sonic device reusable or single-use?

    The Med Sculpt Sonic device is reusable and requires proper storage to maintain its functionality.

  • What is the regulatory classification of the Med Sculpt Sonic device?

    The device is classified as a Class II medical device under FDA regulations with 510(k) clearance (K053041) and is intended for use in physical medicine settings.