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FDA 510(k)

IPL + Diode Laser Machine

K-Number: K193328 · 2020-03-25

Decision Date2020-03-25
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL + Diode Laser Machine is a medical device manufactured by Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2020-03-25 under approval number K193328. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPL + Diode Laser Machine?

IPL + Diode Laser Machine is a medical device that received FDA 510(k) clearance on 2020-03-25. It is manufactured by Beijing Globalipl Development Co., Ltd.. The 510(k) number is K193328.

When was IPL + Diode Laser Machine approved by the FDA?

IPL + Diode Laser Machine received FDA 510(k) clearance on 2020-03-25, under approval number K193328.

What company makes IPL + Diode Laser Machine?

IPL + Diode Laser Machine is manufactured by Beijing Globalipl Development Co., Ltd..

What is the FDA product code for IPL + Diode Laser Machine?

The FDA product code for IPL + Diode Laser Machine is ONF.

Related Clinical Trials

Other Devices by Beijing Globalipl Development Co., Ltd.

Related Devices (Code: ONF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.