Accure Acne, Inc.

Medical device manufacturer in Boulder, CO.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K242035Accure Laser SystemGEX · Traditional 10/11/2024SE
K222109Accure LaserGEX · Traditional 11/17/2022SE

Recalls

RecallProductInitiated
Z-0778-2024 Class IIAccure Laser System, Model: PFMS00004Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of… 12/06/2023Open, Classified