PhotoMedex, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1516-2015Class IIIamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, proMarch 26, 2015
Z-0005-2014Class IIThe product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT FiberJanuary 4, 2013