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FDA 510(k)

Fractional CO2 Laser Machine

K-Number: K250782 · 2025-06-12

ApplicantZhengzhou PZ Laser Slim Technology Co., Ltd.
Decision Date2025-06-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fractional CO2 Laser Machine is a medical device manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-12 under approval number K250782. 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 Machine?

Fractional CO2 Laser Machine is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K250782.

When was Fractional CO2 Laser Machine approved by the FDA?

Fractional CO2 Laser Machine received FDA 510(k) clearance on 2025-06-12, under approval number K250782.

What company makes Fractional CO2 Laser Machine?

Fractional CO2 Laser Machine is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd..

What is the FDA product code for Fractional CO2 Laser Machine?

The FDA product code for Fractional CO2 Laser Machine is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT01619917 The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars RECRUITING NCT05379153 Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial RECRUITING NCT07560332 Oral Propranolol Versus Fractional Carbon Dioxide CO2 Laser Assisted Delivery of Topical Timolol for Treatment of Infantile Hemangioma COMPLETED NCT06295471 A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser RECRUITING NCT06389071 Laser Treatment for Lichen Sclerosus RECRUITING NCT05750901 Evaluation of Fractional Ablative Laser Treatment for Skin Conditions RECRUITING

Other Devices by Zhengzhou PZ Laser Slim Technology Co., Ltd.

K180353Diode laser hair removal device K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) K250038Muscle Stimulator Device (PZ-100) K250041Medical Picosecond ND: YAG Laser System (PZ-6)

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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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