510(k) K151795

ML24000 UVA-1 Phototherapy Cabinet by Daavlin Distributing Co. — Product Code FTC

K151795 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Co. for the device "ML24000 UVA-1 Phototherapy Cabinet". The FDA issued a decision of Substantially Equivalent on September 10, 2015. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Daavlin Distributing Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2015
Date Received
July 2, 2015
Clearance Type
Special
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