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FDA 510(k)

IVYLASER Diode laser hair removal system (IVY-HR-Alloy)

K-Number: K240611 · 2024-06-20

ApplicantIvylaser (Beijing) Technology Co.,Ltd
Decision Date2024-06-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) is a medical device manufactured by Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-06-20 under approval number K240611. 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 IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) is a medical device that received FDA 510(k) clearance on 2024-06-20. It is manufactured by Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K240611.

When was IVYLASER Diode laser hair removal system (IVY-HR-Alloy) approved by the FDA?

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) received FDA 510(k) clearance on 2024-06-20, under approval number K240611.

What company makes IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

IVYLASER Diode laser hair removal system (IVY-HR-Alloy) is manufactured by Ivylaser (Beijing) Technology Co.,Ltd.

What is the FDA product code for IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

The FDA product code for IVYLASER Diode laser hair removal system (IVY-HR-Alloy) 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 Ivylaser (Beijing) Technology Co.,Ltd

K230025IVYLASER Handhold Hair Removal Machine K250206Diode laser system (Night Universe; Predator)

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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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