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FDA 510(k)

PICOSECOND Nd:YAG Laser System

K-Number: K233018 · 2023-12-21

ApplicantIds, Ltd.
Decision Date2023-12-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PICOSECOND Nd:YAG Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Ids, Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K233018. 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?

PICOSECOND Nd:YAG Laser System is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Ids, Ltd.. The 510(k) number is K233018.

When did PICOSECOND Nd:YAG Laser System receive FDA 510(k) clearance?

PICOSECOND Nd:YAG Laser System received FDA 510(k) clearance on 2023-12-21, under 510(k) number K233018.

Who is the listed applicant for PICOSECOND Nd:YAG Laser System?

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

What is the FDA product code for PICOSECOND Nd:YAG Laser System?

The FDA product code for PICOSECOND Nd:YAG Laser System is GEX. This falls under the Gastroenterology category.

Other records listing Ids, Ltd. 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.

K222485SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG LaserK181868SHINY RPL SystemK180036SMAXEL CO2 Surgical Laser SystemK171079Q-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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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