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)

ProFlex Laser Fibers

K-Number: K180140 · 2018-04-20

ApplicantInnovaquartz, LLC
Decision Date2018-04-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ProFlex Laser Fibers is a medical device manufactured by Innovaquartz, LLC. It received FDA 510(k) clearance on 2018-04-20 under approval number K180140. 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 ProFlex Laser Fibers?

ProFlex Laser Fibers is a medical device that received FDA 510(k) clearance on 2018-04-20. It is manufactured by Innovaquartz, LLC. The 510(k) number is K180140.

When was ProFlex Laser Fibers approved by the FDA?

ProFlex Laser Fibers received FDA 510(k) clearance on 2018-04-20, under approval number K180140.

What company makes ProFlex Laser Fibers?

ProFlex Laser Fibers is manufactured by Innovaquartz, LLC.

What is the FDA product code for ProFlex Laser Fibers?

The FDA product code for ProFlex Laser Fibers is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT06795451 Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains RECRUITING

Other Devices by Innovaquartz, LLC

K203799ProFlex CO2 Laser Fiber K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDD

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.

↑