510(k) K070934

PANOSOL II TRU-BLU, MODEL UBL-417 by National Biological Corp. — Product Code FTC

K070934 is an FDA 510(k) premarket notification submitted by National Biological Corp. for the device "PANOSOL II TRU-BLU, MODEL UBL-417". The FDA issued a decision of Substantially Equivalent on May 22, 2007. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. National Biological Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2007
Date Received
April 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type