Beurer IPL 8500 device/ IPL VelvetSkin Pro
K-Number: K181734 · 2018-09-19
ApplicantHome Well Trading, Ltd.
Decision Date2018-09-19
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Beurer IPL 8500 device/ IPL VelvetSkin Pro is a medical device manufactured by Home Well Trading, Ltd.. It received FDA 510(k) clearance on 2018-09-19 under approval number K181734. 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 Beurer IPL 8500 device/ IPL VelvetSkin Pro?
Beurer IPL 8500 device/ IPL VelvetSkin Pro is a medical device that received FDA 510(k) clearance on 2018-09-19. It is manufactured by Home Well Trading, Ltd.. The 510(k) number is K181734.
When was Beurer IPL 8500 device/ IPL VelvetSkin Pro approved by the FDA?
Beurer IPL 8500 device/ IPL VelvetSkin Pro received FDA 510(k) clearance on 2018-09-19, under approval number K181734.
What company makes Beurer IPL 8500 device/ IPL VelvetSkin Pro?
Beurer IPL 8500 device/ IPL VelvetSkin Pro is manufactured by Home Well Trading, Ltd..
What is the FDA product code for Beurer IPL 8500 device/ IPL VelvetSkin Pro?
The FDA product code for Beurer IPL 8500 device/ IPL VelvetSkin Pro is OHT.
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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.