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FDA 510(k)

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)

K-Number: K241670 · 2024-12-20

ApplicantBeijing Adss Development Co., Ltd.
Decision Date2024-12-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K241670. 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 Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)?

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Beijing Adss Development Co., Ltd.. The 510(k) number is K241670.

When did Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) receive FDA 510(k) clearance?

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K241670.

Who is the listed applicant for Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)?

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

What is the FDA product code for Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)?

The FDA product code for Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) is GEX. This falls under the Gastroenterology category.

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Other records listing Beijing Adss Development Co., Ltd. as applicant

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Related Devices (Code: GEX)

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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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