510(k) K110912
K110912 is an FDA 510(k) premarket notification submitted by Daavlin Distributing Co. for the device "SMART TOUCH UVTHERAPY MULTIPLE MACHINE". The FDA issued a decision of Substantially Equivalent on October 20, 2011. 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
- October 20, 2011
- Date Received
- April 1, 2011
- 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