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FDA 510(k)

OMNILUX NEW-U

K-Number: K072459 · 2008-03-03

ApplicantPhoto Therapeutics, Inc.
Decision Date2008-03-03
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNILUX NEW-U is the device name listed in this FDA 510(k) record. The listed applicant is Photo Therapeutics, Inc.. It received FDA 510(k) clearance on 2008-03-03 under 510(k) number K072459. 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 OMNILUX NEW-U?

OMNILUX NEW-U is a medical device that received FDA 510(k) clearance on 2008-03-03. The listed applicant is Photo Therapeutics, Inc.. The 510(k) number is K072459.

When did OMNILUX NEW-U receive FDA 510(k) clearance?

OMNILUX NEW-U received FDA 510(k) clearance on 2008-03-03, under 510(k) number K072459.

Who is the listed applicant for OMNILUX NEW-U?

The FDA 510(k) record lists Photo Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNILUX NEW-U?

The FDA product code for OMNILUX NEW-U is OHS.

Related Clinical Trials

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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Other records listing Photo Therapeutics, Inc. 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.

K081307OMNILUX CLEAR-U

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.

K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)Kam Yuen Plastic Products , Ltd.K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC

Official Source

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