Recall Z-0778-2024— Accure Acne, Inc
Class II · Ongoing
Class II FDA medical device recall by Accure Acne, Inc, initiated 2023-12-06. It names one FDA 510(k) clearance: K222109. Product: Accure Laser System, Model: PFMS00004. Reason: 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..
- Recalling firm
- Accure Acne, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-06
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Accure Laser System, Model: PFMS00004
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.