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FDA 510(k)

Regenalase Laser System

K-Number: K233344 · 2024-05-28

ApplicantIpg Medical
Decision Date2024-05-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Regenalase Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Ipg Medical. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K233344. 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 Regenalase Laser System?

Regenalase Laser System is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Ipg Medical. The 510(k) number is K233344.

When did Regenalase Laser System receive FDA 510(k) clearance?

Regenalase Laser System received FDA 510(k) clearance on 2024-05-28, under 510(k) number K233344.

Who is the listed applicant for Regenalase Laser System?

The FDA 510(k) record lists Ipg Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Regenalase Laser System?

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

Other records listing Ipg Medical 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.

K251100IPGTFL-02K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories

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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