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FDA 510(k)

Diode Laser Hair Removal System (SH-VD910)

K-Number: K240520 · 2024-05-20

ApplicantBeijing Sea Heart International Science and Technologyco.Ltd
Decision Date2024-05-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Hair Removal System (SH-VD910) is a medical device manufactured by Beijing Sea Heart International Science and Technologyco.Ltd. It received FDA 510(k) clearance on 2024-05-20 under approval number K240520. 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 System (SH-VD910)?

Diode Laser Hair Removal System (SH-VD910) is a medical device that received FDA 510(k) clearance on 2024-05-20. It is manufactured by Beijing Sea Heart International Science and Technologyco.Ltd. The 510(k) number is K240520.

When was Diode Laser Hair Removal System (SH-VD910) approved by the FDA?

Diode Laser Hair Removal System (SH-VD910) received FDA 510(k) clearance on 2024-05-20, under approval number K240520.

What company makes Diode Laser Hair Removal System (SH-VD910)?

Diode Laser Hair Removal System (SH-VD910) is manufactured by Beijing Sea Heart International Science and Technologyco.Ltd.

What is the FDA product code for Diode Laser Hair Removal System (SH-VD910)?

The FDA product code for Diode Laser Hair Removal System (SH-VD910) is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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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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