Strata Skin Sciences, Inc.

FDA Regulatory Profile

Strata Skin Sciences, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1455-2017, Class II) was initiated on January 23, 2017. Its most recent 510(k) clearance was granted on January 14, 2020.

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