510(k) K170489
K170489 is an FDA 510(k) premarket notification submitted by Skylit Medical for the device "Skylit Phototherapy System". The FDA issued a decision of Substantially Equivalent on May 23, 2017. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2017
- Date Received
- Feb 17, 2017
- 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
- 510(k)