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FDA 510(k)

Picosecond Nd:YAG Laser System; PICO LEGEND

K-Number: K233007 · 2024-06-12

ApplicantAmi, Inc.
Decision Date2024-06-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Picosecond Nd:YAG Laser System; PICO LEGEND is the device name listed in this FDA 510(k) record. The listed applicant is Ami, Inc.. It received FDA 510(k) clearance on 2024-06-12 under 510(k) number K233007. 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 Picosecond Nd:YAG Laser System; PICO LEGEND?

Picosecond Nd:YAG Laser System; PICO LEGEND is a medical device that received FDA 510(k) clearance on 2024-06-12. The listed applicant is Ami, Inc.. The 510(k) number is K233007.

When did Picosecond Nd:YAG Laser System; PICO LEGEND receive FDA 510(k) clearance?

Picosecond Nd:YAG Laser System; PICO LEGEND received FDA 510(k) clearance on 2024-06-12, under 510(k) number K233007.

Who is the listed applicant for Picosecond Nd:YAG Laser System; PICO LEGEND?

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

What is the FDA product code for Picosecond Nd:YAG Laser System; PICO LEGEND?

The FDA product code for Picosecond Nd:YAG Laser System; PICO LEGEND is GEX. This falls under the Gastroenterology category.

Other records listing Ami, Inc. 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.

K173359Fractional CO2 Surgical Laser SystemK172908Q-Switched Nd:YAG Laser System

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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