Strata Skin Sciences, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1455-2017Class IIXTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for January 23, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K193478XTRAC Momentum Excimer Laser SystemJanuary 14, 2020
K181480MMD TipAugust 1, 2018