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FDA 510(k)

PicoStar

K-Number: K213889 · 2022-04-22

ApplicantAsclepion Laser Technologies GmbH
Decision Date2022-04-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PicoStar 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 2022-04-22 under 510(k) number K213889. 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 PicoStar?

PicoStar is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K213889.

When did PicoStar receive FDA 510(k) clearance?

PicoStar received FDA 510(k) clearance on 2022-04-22, under 510(k) number K213889.

Who is the listed applicant for PicoStar?

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 PicoStar?

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

Other records listing Asclepion Laser Technologies GmbH 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.

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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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