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FDA 510(k)

MANTA Laser

K-Number: K222701 · 2022-11-18

ApplicantSqualus Med , Ltd.
Decision Date2022-11-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MANTA Laser is the device name listed in this FDA 510(k) record. The listed applicant is Squalus Med , Ltd.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222701. 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 MANTA Laser?

MANTA Laser is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Squalus Med , Ltd.. The 510(k) number is K222701.

When did MANTA Laser receive FDA 510(k) clearance?

MANTA Laser received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222701.

Who is the listed applicant for MANTA Laser?

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

What is the FDA product code for MANTA Laser?

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

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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