Leaf Smooth
K-Number: K212697 · 2021-11-19
Decision Date2021-11-19
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Leaf Smooth is a medical device manufactured by Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under approval number K212697. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Leaf Smooth?
Leaf Smooth is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K212697.
When was Leaf Smooth approved by the FDA?
Leaf Smooth received FDA 510(k) clearance on 2021-11-19, under approval number K212697.
What company makes Leaf Smooth?
Leaf Smooth is manufactured by Shenzhen Leaflife Technology Co., Ltd..
What is the FDA product code for Leaf Smooth?
The FDA product code for Leaf Smooth is OHT.
Other Devices by Shenzhen Leaflife Technology Co., Ltd.
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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.