510(k) K220840

1 Series Phototherapy Equipment by Daavlin Distributing Co. — Product Code FTC

K220840 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Co. for the device "1 Series Phototherapy Equipment". The FDA issued a decision of Substantially Equivalent on April 22, 2022. 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
April 22, 2022
Date Received
March 23, 2022
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