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FDA 510(k)

CO2 Laser System (MBT- CO2 Laser)

K-Number: K262269 · 2026-09-01

ApplicantBeijing Mega Beauty Technology Co., Ltd.
Decision Date2026-09-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 Laser System (MBT- CO2 Laser) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Mega Beauty Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-09-01 under 510(k) number K262269. 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 CO2 Laser System (MBT- CO2 Laser)?

CO2 Laser System (MBT- CO2 Laser) is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Beijing Mega Beauty Technology Co., Ltd.. The 510(k) number is K262269.

When did CO2 Laser System (MBT- CO2 Laser) receive FDA 510(k) clearance?

CO2 Laser System (MBT- CO2 Laser) received FDA 510(k) clearance on 2026-09-01, under 510(k) number K262269.

Who is the listed applicant for CO2 Laser System (MBT- CO2 Laser)?

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

What is the FDA product code for CO2 Laser System (MBT- CO2 Laser)?

The FDA product code for CO2 Laser System (MBT- CO2 Laser) is GEX. This falls under the Gastroenterology category.

Other records listing Beijing Mega Beauty Technology 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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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.

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