Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LUNE™ PureHygiene

K-Number: K234085 · 2024-03-25

ApplicantEnamel Pure
Decision Date2024-03-25
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 2024-03-25 under 510(k) number K234085. 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 2024-03-25. The listed applicant is Enamel Pure. The 510(k) number is K234085.

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

LUNE™ PureHygiene received FDA 510(k) clearance on 2024-03-25, under 510(k) number K234085.

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.

K260138LUNE 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.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑