PhotoMedex, Inc.

FDA Regulatory Profile

PhotoMedex, Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1516-2015, Class II) was initiated on March 26, 2015.

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