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FDA 510(k)

MultiPulse TFL

K-Number: K253100 · 2025-10-23

ApplicantAsclepion Laser Technologies GmbH
Decision Date2025-10-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MultiPulse TFL is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2025-10-23 under 510(k) number K253100. 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 MultiPulse TFL?

MultiPulse TFL is a medical device that received FDA 510(k) clearance on 2025-10-23. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K253100.

When did MultiPulse TFL receive FDA 510(k) clearance?

MultiPulse TFL received FDA 510(k) clearance on 2025-10-23, under 510(k) number K253100.

Who is the listed applicant for MultiPulse TFL?

The FDA 510(k) record lists Asclepion Laser Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MultiPulse TFL?

The FDA product code for MultiPulse TFL is GEX. This falls under the Gastroenterology category.

Other records listing Asclepion Laser Technologies GmbH as applicant

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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

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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