Accure Acne, Inc

FDA Regulatory Profile

Accure Acne, Inc appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0778-2024, Class II) was initiated on December 6, 2023. Its most recent 510(k) clearance was granted on October 11, 2024.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0778-2024Class IIAccure Laser System, Model: PFMS00004December 6, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K242035Accure Laser SystemOctober 11, 2024
K222109Accure LaserNovember 17, 2022