510(k) K103708

ML24000 UVA-1 PHOTOTHERAPY UNIT by The Daavlin Distributing Company — Product Code FTC

K103708 is an FDA 510(k) premarket notification submitted by The Daavlin Distributing Company for the device "ML24000 UVA-1 PHOTOTHERAPY UNIT". The FDA issued a decision of Substantially Equivalent on February 22, 2011. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. The Daavlin Distributing Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2011
Date Received
December 20, 2010
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