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)

Diode Laser Hair Removal System

K-Number: K162659 · 2017-06-16

ApplicantShandong Huamei Technology Co., Ltd.
Decision Date2017-06-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Hair Removal System is a medical device manufactured by Shandong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-06-16 under approval number K162659. 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 Diode Laser Hair Removal System?

Diode Laser Hair Removal System is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by Shandong Huamei Technology Co., Ltd.. The 510(k) number is K162659.

When was Diode Laser Hair Removal System approved by the FDA?

Diode Laser Hair Removal System received FDA 510(k) clearance on 2017-06-16, under approval number K162659.

What company makes Diode Laser Hair Removal System?

Diode Laser Hair Removal System is manufactured by Shandong Huamei Technology Co., Ltd..

What is the FDA product code for Diode Laser Hair Removal System?

The FDA product code for Diode Laser Hair Removal System is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07607496 MacuTherm Performance Study in Patients With iAMD NOT_YET_RECRUITING NCT07607028 Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth COMPLETED NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT07062094 Safety and Effectiveness of Orbera365™ Intragastric Balloon System 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) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Shandong Huamei Technology Co., Ltd.

K232982EMS Sculpt Machine

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.

↑