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Accure Laser

by Accure Acne, Inc.

510(k) K222109

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK222109 Date17 Nov 2022ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0778-2024 FDA Class II initiated 6 Dec 2023

    Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.

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  • Withdrawn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, 26 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 is a laser device used for the treatment of mild to severe inflammatory acne vulgaris on the face and body. It operates at a 1726 nm wavelength and features a proprietary 'treat-to-temperature' algorithm and forced-air cooling. The device is designed to target overactive sebaceous glands, a root cause of acne. It is intended to deliver a transformative approach toward clear skin.

The Accure Laser is supplied as a single device and is FDA-cleared. It is designed for use in dermatological applications, specifically for the treatment of acne. The device is available with a product code of GEX and has been assigned the k number K222109. The Accure Laser is used in a clinical setting, such as a dermatologist's office, and is designed to provide safe and optimal treatment of acne.

Other devices from Accure Acne, Inc.

Questions

AI-generated answers, 26 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 used for?

    The Accure Laser is used for the treatment of mild to severe inflammatory acne vulgaris on the face and body, targeting overactive sebaceous glands to deliver clear skin.

  • Is the Accure Laser supplied sterile?

    The description does not specify sterility, but it is designed for use in a clinical setting, such as a dermatologist's office, where proper sanitation and sterilization protocols are typically followed.

  • Is the Accure Laser a single-use device?

    The Accure Laser is supplied as a single device, implying it is designed for multiple uses, but the description does not explicitly state its reuse or single-use status.

  • What is the wavelength of the Accure Laser?

    The Accure Laser operates at a 1726 nm wavelength, which is used to target overactive sebaceous glands, a root cause of acne.