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Greenton Ecolite IPL System

by Greenton (London), Ltd.

510(k) K062721

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 NumberK062721 Date21 Nov 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  • Withdrawn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
GEX
FDA applicant
Greenton (London) , 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, 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 Greenton Ecolite IPL System is a powered laser surgical instrument classified under Powered Laser Surgical Instrument (FDA classification 878.4810). It employs intense pulsed light (IPL) technology to deliver controlled energy for non-invasive dermatological treatments, including hair reduction and vascular lesion management.

This device is intended for single-use applications in clinical settings, such as dermatology and plastic surgery. It operates under FDA 510(k) clearance (K062721) and is regulated as a Class II medical device. No specific sterility or MRI safety data is provided in the submitted records.

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 clinical specialties would typically use the Greenton Ecolite IPL System in their practice?

    The Greenton Ecolite IPL System is primarily designed for use in dermatology and plastic surgery settings. Its intense pulsed light (IPL) technology is intended for non-invasive dermatological treatments like hair reduction and managing vascular lesions, making it a specialized tool for clinicians in these fields.

  • Is the Greenton Ecolite IPL System intended for single-use or repeated use in a clinical setting?

    The Greenton Ecolite IPL System is explicitly intended for single-use applications in clinical settings. This design ensures patient safety and hygiene, as it is not meant to be reused after a single procedure.

  • How is the Greenton Ecolite IPL System regulated, and what does that mean for its use in the U.S.?

    The Greenton Ecolite IPL System is regulated as a Class II medical device under the FDA’s 510(k) clearance pathway (K062721). This means it has undergone a premarket submission process to demonstrate substantial equivalence to a legally marketed predicate device, allowing it to be legally marketed and used in the U.S. for its intended non-invasive dermatological applications.

  • Are there any specific storage requirements mentioned for the Greenton Ecolite IPL System?

    The provided documentation does not include explicit storage instructions for the Greenton Ecolite IPL System. However, since it is intended for single-use, proper handling and storage (e.g., in a clean, dry environment away from direct sunlight) should be followed to maintain device integrity until use.