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FDA 510(k)

PURE Laser

K-Number: K222369 · 2022-10-07

ApplicantEndymed Medical, Ltd.
Decision Date2022-10-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PURE Laser is the device name listed in this FDA 510(k) record. The listed applicant is Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K222369. 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 PURE Laser?

PURE Laser is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Endymed Medical, Ltd.. The 510(k) number is K222369.

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

PURE Laser received FDA 510(k) clearance on 2022-10-07, under 510(k) number K222369.

Who is the listed applicant for PURE Laser?

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

What is the FDA product code for PURE Laser?

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

Other records listing Endymed Medical, 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.

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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.

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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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