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FDA 510(k)

LED Light Therapy Mask (model: MK66R-B)

K-Number: K221946 · 2022-11-22

ApplicantLight Tree Ventures Europe B.V.
Decision Date2022-11-22
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Mask (model: MK66R-B) is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221946. 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 LED Light Therapy Mask (model: MK66R-B)?

LED Light Therapy Mask (model: MK66R-B) is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K221946.

When did LED Light Therapy Mask (model: MK66R-B) receive FDA 510(k) clearance?

LED Light Therapy Mask (model: MK66R-B) received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221946.

Who is the listed applicant for LED Light Therapy Mask (model: MK66R-B)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Mask (model: MK66R-B)?

The FDA product code for LED Light Therapy Mask (model: MK66R-B) is OHS.

Related Clinical Trials

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NCT07661004Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .NOT_YET_RECRUITING

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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

View on FDA Database →

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

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