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Accure Laser System

by Accure Acne, Inc.

510(k) K242035

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 NumberK242035 Date11 Oct 2024ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Accure Laser System is a laser device used for the treatment of mild to severe inflammatory acne vulgaris on the face and body. It utilizes a 1726 nm wavelength laser with a proprietary algorithm and forced-air cooling. The device is designed to target overactive sebaceous glands, a root cause of acne. It operates by delivering a precise treatment based on temperature. The Accure Laser System is intended to provide a transformative approach towards clear skin.

The Accure Laser System is supplied as a single device and is cleared for long-term management of acne. It has received FDA 510K clearance. The device is designed for use in dermatological settings, such as clinics or hospitals, and is intended for use by dermatologists. The system is designed to ensure safe and optimal treatment of acne.

Other devices from Accure Acne, Inc.

  • Accure Laser Open recall

    Class II

Questions

AI-generated answers, 24 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 Accure Laser System used for?

    The Accure Laser System is a laser device designed for the treatment of mild to severe inflammatory acne vulgaris on the face and body. It targets overactive sebaceous glands, which are a root cause of acne, by delivering precise temperature-based treatments.

  • How is the Accure Laser System supplied?

    The Accure Laser System is supplied as a single device intended for use in dermatological settings such as clinics or hospitals. It is designed to be operated by dermatologists for the safe and optimal treatment of acne.

  • What wavelength does the Accure Laser System use and how does it work?

    The Accure Laser System utilizes a 1726 nm wavelength laser with a proprietary algorithm and forced-air cooling. It operates by delivering precise treatments based on temperature to target overactive sebaceous glands, providing a transformative approach toward clear skin.

  • What is the regulatory status of the Accure Laser System?

    The Accure Laser System has received FDA 510K clearance for the long-term management of acne. It is classified under product code GEX and was determined to be substantially equivalent through the traditional clearance pathway.