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FDA 510(k)

Diode Laser Hair Removal Machine

K-Number: K192735 · 2020-04-03

ApplicantBeijing Lead Beauty S & T Co., Ltd.
Decision Date2020-04-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Hair Removal Machine is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Lead Beauty S & T Co., Ltd.. It received FDA 510(k) clearance on 2020-04-03 under 510(k) number K192735. 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 Machine?

Diode Laser Hair Removal Machine is a medical device that received FDA 510(k) clearance on 2020-04-03. The listed applicant is Beijing Lead Beauty S & T Co., Ltd.. The 510(k) number is K192735.

When did Diode Laser Hair Removal Machine receive FDA 510(k) clearance?

Diode Laser Hair Removal Machine received FDA 510(k) clearance on 2020-04-03, under 510(k) number K192735.

Who is the listed applicant for Diode Laser Hair Removal Machine?

The FDA 510(k) record lists Beijing Lead Beauty S & T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser Hair Removal Machine?

The FDA product code for Diode Laser Hair Removal Machine is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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NCT07759076Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical StudyNOT_YET_RECRUITING

Other records listing Beijing Lead Beauty S & T Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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