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FDA 510(k)

GENTLEWAVES LED PHOTOMODULATION DEVICE

K-Number: K031425 · 2004-12-15

ApplicantLight Bioscience, LLC
Decision Date2004-12-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENTLEWAVES LED PHOTOMODULATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Light Bioscience, LLC. It received FDA 510(k) clearance on 2004-12-15 under 510(k) number K031425. 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 GENTLEWAVES LED PHOTOMODULATION DEVICE?

GENTLEWAVES LED PHOTOMODULATION DEVICE is a medical device that received FDA 510(k) clearance on 2004-12-15. The listed applicant is Light Bioscience, LLC. The 510(k) number is K031425.

When did GENTLEWAVES LED PHOTOMODULATION DEVICE receive FDA 510(k) clearance?

GENTLEWAVES LED PHOTOMODULATION DEVICE received FDA 510(k) clearance on 2004-12-15, under 510(k) number K031425.

Who is the listed applicant for GENTLEWAVES LED PHOTOMODULATION DEVICE?

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

What is the FDA product code for GENTLEWAVES LED PHOTOMODULATION DEVICE?

The FDA product code for GENTLEWAVES LED PHOTOMODULATION DEVICE is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Light Bioscience, LLC 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.

K062991GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE

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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