Aesthetics Systems Usa Inc

FDA Regulatory Profile

Aesthetics Systems Usa Inc appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0029-2022, Class I) was initiated on August 23, 2021.

Summary

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

Recent Recalls

NumberClassProductDate
Z-0029-2022Class IAction De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrAugust 23, 2021