Accure Acne, Inc recalls Accure Laser System, Model: PFMS00004

Recall date

December 6, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0778-2024

FDA classification

Class II

Brand / firm

Accure Acne, Inc

Sold / distributed

US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Accure Laser System, Model: PFMS00004