510(k) K191086
K191086 is an FDA 510(k) premarket notification submitted by Clarteis for the device "Exciplex". The FDA issued a decision of Substantially Equivalent on December 11, 2019. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Clarteis has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2019
- Date Received
- April 24, 2019
- 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