# K222109: Accure Laser

- Pathway: 510(k) (Traditional)
- Applicant: Accure Acne, Inc.
- Decided: Nov 17, 2022 after 122 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Dec 6, 2023 · Class II · Z-0778-2024: 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.

## Indications for use
The Accure Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K222109
Methodology: https://510kreport.com/methodology