Recall Z-1779-2013— National Biological Corp
Class III · Terminated
Class III FDA medical device recall by National Biological Corp, initiated 2013-04-08, terminated 2014-02-24. It names one FDA 510(k) clearance: K903660. Product: Dermalight 80 Model Number UVB-083, 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.. Reason: The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device..
- Recalling firm
- National Biological Corp
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-04-08
- Terminated
- 2014-02-24
- Firm location
- Beachwood, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Dermalight 80 Model Number UVB-083, 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.
Reason for recall
The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.