FDA-Device2013-07-31Class III

Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

National Biological Corp
Hazard

The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.

Sold states
Worldwide distribution: US (nationwide) including states of: AL, CA, CO, CT, FL, GA, IA, ID, IL, LA, MA, MN, MO, MS, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI; and countries of: Canada, Brazil, Malaysia, and Mexico.
Affected count
124 units
Manufactured in
23700 Mercantile Rd, N/A, Beachwood, OH, United States
Products
Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1778-2013

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