Raycell Mk2
K-Number: K161324 · 2016-08-12
ApplicantBest Theratronics Limited
Decision Date2016-08-12
Product CodeMOT
DecisionSubstantially Equivalent
Device Summary
Raycell Mk2 is a medical device manufactured by Best Theratronics Limited. It received FDA 510(k) clearance on 2016-08-12 under approval number K161324. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Raycell Mk2?
Raycell Mk2 is a medical device that received FDA 510(k) clearance on 2016-08-12. It is manufactured by Best Theratronics Limited. The 510(k) number is K161324.
When was Raycell Mk2 approved by the FDA?
Raycell Mk2 received FDA 510(k) clearance on 2016-08-12, under approval number K161324.
What company makes Raycell Mk2?
Raycell Mk2 is manufactured by Best Theratronics Limited.
What is the FDA product code for Raycell Mk2?
The FDA product code for Raycell Mk2 is MOT.
Other Devices by Best Theratronics Limited
Related Devices (Code: MOT)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.