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UltraShape System

by Syneron Medical Ltd 3 variants

510(k) K162163

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 NumberK162163 Date17 Nov 2016ClearedStatusActive

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  • Withdrawn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
OHV
FDA applicant
Syneron Medical, Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4590
Advisory Committee
General, Plastic Surgery
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 UltraShape System is a focused ultrasound device for tissue heat or mechanical cellular disruption. It is designed to deliver focused ultrasound energy that disrupts subcutaneous adipose tissue for lipolysis.

The system is supplied as a non-invasive device intended for use in general and plastic surgery settings. It has received FDA 510(k) clearance under product code OHV and regulation number 878.4590, with classification as a Class II medical device.

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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 UltraShape System intended to do?

    The UltraShape System is designed to deliver focused ultrasound energy that disrupts subcutaneous adipose tissue for lipolysis, using tissue heat or mechanical cellular disruption as its mechanism of action.

  • In what clinical settings is the UltraShape System intended to be used?

    The system is supplied as a non-invasive device intended for use in general and plastic surgery settings, as specified in its description and regulatory documentation.

  • What regulatory pathway was used for the UltraShape System's market authorization?

    The UltraShape System received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) review process.

  • How is the UltraShape System classified under FDA regulations?

    The device is classified as a Class II medical device under FDA regulation number 878.4590 and product code OHV, as indicated in its authorization and openFDA data.

  • What does the FDA 510(k) clearance number K162163 signify for the UltraShape System?

    The K162163 number identifies the specific 510(k) submission under which the UltraShape System was cleared by the FDA, confirming its substantial equivalence to a predicate device and authorization for market distribution.