510(k) K073587

DERMAPAL WITH DIGITAL TIMER by Daavlin Distributing Co. — Product Code FTC

K073587 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Co. for the device "DERMAPAL WITH DIGITAL TIMER". The FDA issued a decision of Substantially Equivalent on January 18, 2008. 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
January 18, 2008
Date Received
December 20, 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