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)

Q-Switched Nd:YAG Laser Therapy Systems

K-Number: K163123 · 2017-02-02

ApplicantBeijing Sincoheren Science and Technology Development Co.
Decision Date2017-02-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Q-Switched Nd:YAG Laser Therapy Systems is a medical device manufactured by Beijing Sincoheren Science and Technology Development Co.. It received FDA 510(k) clearance on 2017-02-02 under approval number K163123. 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 Q-Switched Nd:YAG Laser Therapy Systems?

Q-Switched Nd:YAG Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-02-02. It is manufactured by Beijing Sincoheren Science and Technology Development Co.. The 510(k) number is K163123.

When was Q-Switched Nd:YAG Laser Therapy Systems approved by the FDA?

Q-Switched Nd:YAG Laser Therapy Systems received FDA 510(k) clearance on 2017-02-02, under approval number K163123.

What company makes Q-Switched Nd:YAG Laser Therapy Systems?

Q-Switched Nd:YAG Laser Therapy Systems is manufactured by Beijing Sincoheren Science and Technology Development Co..

What is the FDA product code for Q-Switched Nd:YAG Laser Therapy Systems?

The FDA product code for Q-Switched Nd:YAG Laser Therapy Systems is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07615361 Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy ENROLLING_BY_INVITATION NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT07615920 HILT vs ESWT in Supraspinatus Tendinitis NOT_YET_RECRUITING NCT05738239 Photo-biomodulation Therapy for Pain Relief After Caesarean Section COMPLETED NCT07137728 Dual Frequency Low-Level Laser Therapy in Myofascial Trigger Points of Upper Trapezius COMPLETED NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED

Related PubMed Literature

PMID: 41483832 Emerging nanodelivery systems for cuproptosis induction: design strategies and multidimensional regulatory mechanisms. International journal of pharmaceutics (2026) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

Other Devices by Beijing Sincoheren Science and Technology Development Co.

K162398CO2 Laser Therapy Systems

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.

↑