510(k) K173436
K173436 is an FDA 510(k) premarket notification submitted by Luma Therapeutics for the device "Luma Light System". The FDA issued a decision of Substantially Equivalent on Jan 30, 2018. 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
- Jan 30, 2018
- Date Received
- Nov 3, 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)