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FDA 510(k)

LUNE PureHygiene

K-Number: K260138 · 2026-05-29

ApplicantEnamel Pure
Decision Date2026-05-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUNE PureHygiene is the device name listed in this FDA 510(k) record. The listed applicant is Enamel Pure. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K260138. 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 LUNE PureHygiene?

LUNE PureHygiene is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Enamel Pure. The 510(k) number is K260138.

When did LUNE PureHygiene receive FDA 510(k) clearance?

LUNE PureHygiene received FDA 510(k) clearance on 2026-05-29, under 510(k) number K260138.

Who is the listed applicant for LUNE PureHygiene?

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

What is the FDA product code for LUNE PureHygiene?

The FDA product code for LUNE PureHygiene is GEX. This falls under the Gastroenterology category.

Other records listing Enamel Pure 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.

K234085LUNE™ PureHygiene

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.

K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K262070Diode Laser Therapy Systems (DL612A)Hebei Zollvan Medical Technology Co., Ltd.K261964ECHOLASER X4Elesta S.P.AK261841Q 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.

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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