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FDA 510(k)

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

K-Number: K232117 · 2023-11-28

ApplicantWuhan Lotuxs Technology Co., Ltd.
Decision Date2023-11-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is a medical device manufactured by Wuhan Lotuxs Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-28 under approval number K232117. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is a medical device that received FDA 510(k) clearance on 2023-11-28. It is manufactured by Wuhan Lotuxs Technology Co., Ltd.. The 510(k) number is K232117.

When was Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) approved by the FDA?

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) received FDA 510(k) clearance on 2023-11-28, under approval number K232117.

What company makes Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is manufactured by Wuhan Lotuxs Technology Co., Ltd..

What is the FDA product code for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

The FDA product code for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other Devices by Wuhan Lotuxs Technology Co., Ltd.

K191068Powersculp laser lipolysis system K230090Diode Laser Hair Removal K231910DermRays Revive

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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.

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