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FDA 510(k)

myLEDmask

K-Number: K223147 · 2023-05-14

ApplicantMyblend
Decision Date2023-05-14
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

myLEDmask is the device name listed in this FDA 510(k) record. The listed applicant is Myblend. It received FDA 510(k) clearance on 2023-05-14 under 510(k) number K223147. 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 myLEDmask?

myLEDmask is a medical device that received FDA 510(k) clearance on 2023-05-14. The listed applicant is Myblend. The 510(k) number is K223147.

When did myLEDmask receive FDA 510(k) clearance?

myLEDmask received FDA 510(k) clearance on 2023-05-14, under 510(k) number K223147.

Who is the listed applicant for myLEDmask?

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

What is the FDA product code for myLEDmask?

The FDA product code for myLEDmask is OHS.

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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.

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

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