Recall Z-1516-2015— PhotoMedex, Inc.

Name: FDA recall Z-1516-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-26

Class II · Terminated

Class II FDA medical device recall by PhotoMedex, Inc., initiated 2015-03-26, terminated 2015-08-18. It names 2 FDA 510(k) clearances: K964468, K953853. Product: Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.. Reason: The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these devices..

Recalling firm: PhotoMedex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-26
Terminated: 2015-08-18
Firm location: Horsham, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K964468 — IAMIN WET DRESSING (COPPER-SALINE)Procyte Corp.·cleared 1997-02-03
K953853 — IAMIN GEL WOUND DRESSINGProcyte Corp.·cleared 1996-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.

Reason for recall

The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these devices.

Data sourced from openFDA. This site is unofficial and independent of the FDA.