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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 the device name listed in this FDA 510(k) record. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-06-20 under 510(k) 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. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K240611.

When did IVYLASER Diode laser hair removal system (IVY-HR-Alloy) receive FDA 510(k) clearance?

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

Who is the listed applicant for IVYLASER Diode laser hair removal system (IVY-HR-Alloy)?

The FDA 510(k) record lists Ivylaser (Beijing) Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Ivylaser (Beijing) Technology Co.,Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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