FDA applicant

Accure Acne, Inc.

Boulder, CO2 decisions2022–20241 recall

FDA records 2 decisions for Accure Acne, Inc. (Boulder, CO) from 2022 to 2024: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Accure Acne, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2023

2022high 1 (2023) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Accure Acne, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Accure Acne, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Accure Acne, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?