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FDA 510(k)

SMAXEL CO2 Surgical Laser System

K-Number: K180036 · 2018-02-02

ApplicantIds, Ltd.
Decision Date2018-02-02
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMAXEL CO2 Surgical Laser System is a medical device manufactured by Ids, Ltd.. It received FDA 510(k) clearance on 2018-02-02 under approval number K180036. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMAXEL CO2 Surgical Laser System?

SMAXEL CO2 Surgical Laser System is a medical device that received FDA 510(k) clearance on 2018-02-02. It is manufactured by Ids, Ltd.. The 510(k) number is K180036.

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

SMAXEL CO2 Surgical Laser System received FDA 510(k) clearance on 2018-02-02, under approval number K180036.

What company makes SMAXEL CO2 Surgical Laser System?

SMAXEL CO2 Surgical Laser System is manufactured by Ids, Ltd..

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

The FDA product code for SMAXEL CO2 Surgical Laser System is ONG.

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: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) 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) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Ids, Ltd.

K171079Q-Switched Nd:YAG Laser System K181868SHINY RPL System K233018PICOSECOND Nd:YAG Laser System

Related Devices (Code: ONG)

K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. K182498Advanced Skin Renewing DeviceJiangsu Unimed Laser Technology Co., Ltd. K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics , Ltd. K202884SR-1 Skin Treatment SystemAVAVA, Inc. K221268SR-1 Skin Treatment SystemAVAVA, Inc. K221770Fiber Laser Treatment SystemShanghai Apolo 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.

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