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FDA 510(k)

Fractional CO2 Surgical Laser System

K-Number: K173359 · 2018-07-05

ApplicantAmi, Inc.
Decision Date2018-07-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fractional CO2 Surgical Laser System is a medical device manufactured by Ami, Inc.. It received FDA 510(k) clearance on 2018-07-05 under approval number K173359. 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 Surgical Laser System?

Fractional CO2 Surgical Laser System is a medical device that received FDA 510(k) clearance on 2018-07-05. It is manufactured by Ami, Inc.. The 510(k) number is K173359.

When was Fractional CO2 Surgical Laser System approved by the FDA?

Fractional CO2 Surgical Laser System received FDA 510(k) clearance on 2018-07-05, under approval number K173359.

What company makes Fractional CO2 Surgical Laser System?

Fractional CO2 Surgical Laser System is manufactured by Ami, Inc..

What is the FDA product code for Fractional CO2 Surgical Laser System?

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

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Ami, Inc.

K172908Q-Switched Nd:YAG Laser System K233007Picosecond Nd:YAG Laser System; PICO LEGEND

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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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