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FDA 510(k)

UltraClear Fractional Laser System

K-Number: K210847 · 2021-12-10

ApplicantFa International, LP
Decision Date2021-12-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraClear Fractional Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Fa International, LP. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K210847. 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 UltraClear Fractional Laser System?

UltraClear Fractional Laser System is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Fa International, LP. The 510(k) number is K210847.

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

UltraClear Fractional Laser System received FDA 510(k) clearance on 2021-12-10, under 510(k) number K210847.

Who is the listed applicant for UltraClear Fractional Laser System?

The FDA 510(k) record lists Fa International, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraClear Fractional Laser System?

The FDA product code for UltraClear Fractional Laser System 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.

NCT07759817Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment AreasNOT_YET_RECRUITING

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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