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 the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-12 under 510(k) 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. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K250782.

When did Fractional CO2 Laser Machine receive FDA 510(k) clearance?

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

Who is the listed applicant for Fractional CO2 Laser Machine?

The FDA 510(k) record lists Zhengzhou PZ Laser Slim Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT04198454Compression and CO2 Laser for Leg WoundsENROLLING_BY_INVITATION NCT05379153Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize TrialRECRUITING NCT05411484Investigation of Laser Assisted Drug Delivery of NanoDOX®ACTIVE_NOT_RECRUITING NCT06295471A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 LaserRECRUITING NCT07560332Oral Propranolol Versus Fractional Carbon Dioxide CO2 Laser Assisted Delivery of Topical Timolol for Treatment of Infantile HemangiomaCOMPLETED NCT07639151Effectiveness and Safety of a Hydrating Gel Containing Polyvinyl Pyrrolidine, Algin and Hyaluronic Acid Applied After and Without Fractional CO₂ Laser TherapyNOT_YET_RECRUITING

Other records listing Zhengzhou PZ Laser Slim Technology Co., Ltd. as applicant

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)K180353Diode laser hair removal device

Related Devices (Code: GEX)

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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.