510(k) K050695
K050695 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Co. for the device "FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT". The FDA issued a decision of Substantially Equivalent on April 19, 2005. 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 19, 2005
- Date Received
- March 18, 2005
- 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