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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 a medical device manufactured by Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2024-12-20 under approval 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. It is manufactured by Beijing Adss Development Co., Ltd.. The 510(k) number is K241670.

When was Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) approved by the FDA?

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

What company makes 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 manufactured by Beijing Adss Development Co., Ltd..

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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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Beijing Adss Development Co., Ltd.

K161692Diode Laser Therapy Machine K161925CO2 Laser Therapy Machine K161286IPL Therapy Machine K161926ND YAG Q-switch Laser Therapy Machine K192295PDT-FACE K220268Picosecond Laser System (Model PS10-A and PS10-B)

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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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