Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
K-Number: K181121 · 2018-06-28
ApplicantHome Well Trading, Ltd.
Decision Date2018-06-28
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro is a medical device manufactured by Home Well Trading, Ltd.. It received FDA 510(k) clearance on 2018-06-28 under approval number K181121. 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 5500 device/ IPL 5000/ IPL PureSkin Pro?
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro is a medical device that received FDA 510(k) clearance on 2018-06-28. It is manufactured by Home Well Trading, Ltd.. The 510(k) number is K181121.
When was Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro approved by the FDA?
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro received FDA 510(k) clearance on 2018-06-28, under approval number K181121.
What company makes Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro?
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro is manufactured by Home Well Trading, Ltd..
What is the FDA product code for Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro?
The FDA product code for Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro is OHT.
Other Devices by Home Well Trading, Ltd.
Related Devices (Code: OHT)
K162231iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expertCyden Limited
K161089sensiLight MiniEl Global Trade, Ltd.
K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited
K172181micro IPLEl Global Trade, Ltd.
K171433Silk'n InfinityHome Skinovations , Ltd.
K170269Hee HR MiniOriental Inspiration Limited
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.