Device 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.
Z-1516-2015
Product summary
- Firm
- PhotoMedex, Inc.
- Event
- Event 70838
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200188
- Official record key
device-enforcement:Z-1516-2015
Official wording
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.
Code information: Item No. Description GCICK Iamin After-Care Kit GC044-1 Iamin Moist Dressing (1) GCIMD Iamin Moist Dressing Kit (7) GCIHG Iamin Hydrating Gel Kit M40329 Iamin Hydrating Gel 15g 20920. Insert, Iamin Care 6 x 4 20939. Iamin Kit Box (GCICK/GCICK) P-GCI624A Iamin Patient Brochure (25) PK PNI-624A Iamin Detail Brochure (25) PK
Distribution pattern: Nationwide and Internationally, including Canada.
Derived failure modes
-
Unknown
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.