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FDA 510(k)

GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE

K-Number: K062991 · 2008-02-15

ApplicantLight Bioscience, LLC
Decision Date2008-02-15
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENTLEWAVES CONSUMER 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 2008-02-15 under 510(k) number K062991. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE?

GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE is a medical device that received FDA 510(k) clearance on 2008-02-15. The listed applicant is Light Bioscience, LLC. The 510(k) number is K062991.

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

GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE received FDA 510(k) clearance on 2008-02-15, under 510(k) number K062991.

Who is the listed applicant for GENTLEWAVES CONSUMER 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 CONSUMER LED PHOTOMODULATION DEVICE?

The FDA product code for GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE is OHS.

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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.

K031425GENTLEWAVES LED PHOTOMODULATION DEVICE

Related Devices (Code: OHS)

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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