Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Lumenis Y&R Laser System

K-Number: K211979 · 2022-06-21

ApplicantLumenis, Inc.
Decision Date2022-06-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lumenis Y&R Laser System is a medical device manufactured by Lumenis, Inc.. It received FDA 510(k) clearance on 2022-06-21 under approval number K211979. 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 Lumenis Y&R Laser System?

Lumenis Y&R Laser System is a medical device that received FDA 510(k) clearance on 2022-06-21. It is manufactured by Lumenis, Inc.. The 510(k) number is K211979.

When was Lumenis Y&R Laser System approved by the FDA?

Lumenis Y&R Laser System received FDA 510(k) clearance on 2022-06-21, under approval number K211979.

What company makes Lumenis Y&R Laser System?

Lumenis Y&R Laser System is manufactured by Lumenis, Inc..

What is the FDA product code for Lumenis Y&R Laser System?

The FDA product code for Lumenis Y&R Laser System is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07607496 MacuTherm Performance Study in Patients With iAMD NOT_YET_RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT06795451 Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains RECRUITING NCT07340671 Facial Papules in Frontal Fibrosing Alopecia (FFA) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , 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.

↑