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FDA 510(k)

Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

K-Number: K242987 · 2024-12-17

ApplicantAllengers Global Healthcare Private Limited
Decision Date2024-12-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thulium Fiber Laser (FiberLAZE+, FiberLAZE) is the device name listed in this FDA 510(k) record. The listed applicant is Allengers Global Healthcare Private Limited. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K242987. 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 Thulium Fiber Laser (FiberLAZE+, FiberLAZE)?

Thulium Fiber Laser (FiberLAZE+, FiberLAZE) is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Allengers Global Healthcare Private Limited. The 510(k) number is K242987.

When did Thulium Fiber Laser (FiberLAZE+, FiberLAZE) receive FDA 510(k) clearance?

Thulium Fiber Laser (FiberLAZE+, FiberLAZE) received FDA 510(k) clearance on 2024-12-17, under 510(k) number K242987.

Who is the listed applicant for Thulium Fiber Laser (FiberLAZE+, FiberLAZE)?

The FDA 510(k) record lists Allengers Global Healthcare Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thulium Fiber Laser (FiberLAZE+, FiberLAZE)?

The FDA product code for Thulium Fiber Laser (FiberLAZE+, FiberLAZE) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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.

NCT06721975Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)RECRUITINGNCT07087977HoYAG vs TFL in miniPCNL With ClearPetraRECRUITING

Other records listing Allengers Global Healthcare Private Limited 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.

K231718Holmium Medical Laser

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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