FDA-Device2015-04-29Class II

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.

PhotoMedex, Inc.
Hazard

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.

Sold states
Nationwide and Internationally, including Canada.
Affected count
200188
Manufactured in
100 Lakeside Dr, Horsham, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1516-2015

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