Skip to content

Aurora DS

by Syneron Medical Ltd 3 variants

510(k) K021149

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 NumberK021149 Date9 Jul 2002ClearedStatusActive

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  • Withdrawn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
GEX
FDA applicant
Syneron Medical, Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Aurora DS is a device classified under product code GEX for General and Plastic Surgery applications. It received FDA 510(k) clearance as substantially equivalent to a predicate device through the traditional review pathway.

The device was cleared by the FDA on July 9, 2002, under K021149. It is manufactured by Syneron Medical Ltd. and is authorized for use in the United States.

Other devices from Syneron Medical Ltd

See all devices from Syneron Medical Ltd →

Questions

AI-generated answers, 6 Oct 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 Aurora DS used for?

    The Aurora DS is classified under product code GEX for General and Plastic Surgery applications, indicating its use in procedures within these surgical specialties as determined by its FDA 510(k) clearance.

  • How was the Aurora DS cleared for use in the United States?

    The Aurora DS received FDA 510(k) clearance through the traditional review pathway, being found substantially equivalent to a predicate device, which allowed its authorization for use in the United States.

  • When did the Aurora DS receive FDA clearance?

    The Aurora DS was cleared by the FDA on July 9, 2002, under K-number K021149, following its submission on April 10, 2002, and a traditional 510(k) review process.