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FDA 510(k)

Project E Beauty LED Light Therapy Mask (Model: PE730)

K-Number: K214101 · 2022-03-23

ApplicantDuplex International Trading Limited
Decision Date2022-03-23
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Project E Beauty LED Light Therapy Mask (Model: PE730) is the device name listed in this FDA 510(k) record. The listed applicant is Duplex International Trading Limited. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K214101. 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 Project E Beauty LED Light Therapy Mask (Model: PE730)?

Project E Beauty LED Light Therapy Mask (Model: PE730) is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Duplex International Trading Limited. The 510(k) number is K214101.

When did Project E Beauty LED Light Therapy Mask (Model: PE730) receive FDA 510(k) clearance?

Project E Beauty LED Light Therapy Mask (Model: PE730) received FDA 510(k) clearance on 2022-03-23, under 510(k) number K214101.

Who is the listed applicant for Project E Beauty LED Light Therapy Mask (Model: PE730)?

The FDA 510(k) record lists Duplex International Trading Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Project E Beauty LED Light Therapy Mask (Model: PE730)?

The FDA product code for Project E Beauty LED Light Therapy Mask (Model: PE730) 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.

NCT07370051Effect of Topical Oxygen and LED Light Therapy on Nipple CrackNOT_YET_RECRUITINGNCT07681921Randomized Clinical Investigation of Photobiomodulation (PBM) for the Management of Early Peripheral Neuropathy Related to Medical Oncologic TherapyNOT_YET_RECRUITINGNCT05543720Evaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT StudyACTIVE_NOT_RECRUITINGNCT07232667Digital Technology for Active and Healthy Ageing in TaiwanRECRUITINGNCT07620834Artificial Intelligence-Guided Diagnosis for High-Risk Osteoporosis Populations: A Pragmatic Randomized Clinical TrialRECRUITINGNCT07661004Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .NOT_YET_RECRUITING

Other records listing Duplex International Trading Limited 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.

K261496LED Light Therapy Masks (PE748, PE749, PE756)

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.

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, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, 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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