FDA-Device2024-01-31Class II
Accure Laser System, Model: PFMS00004
Accure Acne, Inc
Hazard
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.
Sold states
US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
Affected count
22
Manufactured in
4699 Nautilus Ct S Ste 205, N/A, Boulder, CO, United States
Products
Accure Laser System, Model: PFMS00004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0778-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief