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FDA 510(k)

US 450 Diode Laser Equipment

K-Number: K222916 · 2022-12-09

ApplicantBeijing Globalipl Development Co., Ltd.
Decision Date2022-12-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

US 450 Diode Laser Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222916. 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 US 450 Diode Laser Equipment?

US 450 Diode Laser Equipment is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Beijing Globalipl Development Co., Ltd.. The 510(k) number is K222916.

When did US 450 Diode Laser Equipment receive FDA 510(k) clearance?

US 450 Diode Laser Equipment received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222916.

Who is the listed applicant for US 450 Diode Laser Equipment?

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

What is the FDA product code for US 450 Diode Laser Equipment?

The FDA product code for US 450 Diode Laser Equipment is GEX. This falls under the Gastroenterology category.

Other records listing Beijing Globalipl Development 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.

K220385Intense Pulsed Light EquipmentK212611CO2 Laser EquipmentK193328IPL + Diode Laser 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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