Psoria-Shield® Inc., a Tampa, Fla. designer and manufacturer specializing in medical devices, announced today it has achieved the prestigious medical-grade ISO 13485 quality system certification. Further, Psoria-Shield announced that its flagship medical device, the Psoria-Light®, has received its CE certification. These announcements came just before their unveiling to the international medical device community at the MEDICA tradeshow this year in Dusseldorf, Germany, November 16 – 19.
Psoria-Light delivers Deep UV LED targeted phototherapy treatment to patients with UV treatable skin conditions, including but not limited to psoriasis, eczema and vitiligo. Targeted UV phototherapy involves the delivery of high dosages of UV light to only affected tissues, sparing healthy skin. Psoria-Light is capable of emitting either UVA or NB-UVB light, allowing healthcare providers access to multiple forms of phototherapy treatment, all within one device. Because Psoria-Light emits very intense levels of UV light, it can only be sold to qualified healthcare providers and is not for home use. Psoria-Light’s revolutionary patent-pending technology is recognized exclusively by the Space Foundation as a Certified Space Technology.
Psoria-Shield has demonstrated their ongoing commitment to the highest standards of design and manufacturing through ISO 13485 quality management system certification. CE marking is a conformity mark required for medical devices sold in the European Economic Area (EEA), consisting of the 27 member states of the EU and EFTA countries. Psoria-Light is an FDA 510(k) cleared medical device, carries the CE mark, and is manufactured under an ISO 13485 medical grade quality system.
Psoriasis, eczema, vitiligo and other UV-treatable skin disorders affect patients worldwide. Psoria-Light technology can now increase patient access to safe, effective targeted UV phototherapy to patients in the EEA.
Kevin Cook, director of Space Awareness Programs for the Space Foundation, will be in attendance with Psoria-Shield at this year’s MEDICA event. Visit Psoria-Shield at MEDICA Hall 10 Booth B48, and email to schedule a demonstration while at the show.
For more information on Psoria-Light Deep UV LED targeted phototherapy, visit: www.psoria-shield.com
For more information on Space Certification recognition, visit: www.spaceconnection.org
About Psoria‐Shield: Psoria‐Shield advocates the use of targeted UV phototherapy to address those aspects of patients’ disease which reduce their Quality of Life the most, first. By addressing the major detractors from patients’ Quality of Life initially, patients and healthcare providers can address the remaining regions of skin with less aggressive therapy.
MEDIA CONTACT
Lux Dynamics LLC
(813) 468‐1161
www.psoria‐shield.com
SOURCE: Psoria-Shield® Inc.
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