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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 a medical device manufactured by Ami, Inc.. It received FDA 510(k) clearance on 2024-06-12 under approval 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. It is manufactured by Ami, Inc.. The 510(k) number is K233007.

When was Picosecond Nd:YAG Laser System; PICO LEGEND approved by the FDA?

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

What company makes Picosecond Nd:YAG Laser System; PICO LEGEND?

Picosecond Nd:YAG Laser System; PICO LEGEND is manufactured by Ami, Inc..

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.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Ami, Inc.

K172908Q-Switched Nd:YAG Laser System K173359Fractional CO2 Surgical Laser System

Related Devices (Code: GEX)

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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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