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FDA 510(k)

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

K-Number: K260150 · 2026-04-22

ApplicantNOOANCE
Decision Date2026-04-22
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is the device name listed in this FDA 510(k) record. The listed applicant is NOOANCE. It received FDA 510(k) clearance on 2026-04-22 under 510(k) number K260150. 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 FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is a medical device that received FDA 510(k) clearance on 2026-04-22. The listed applicant is NOOANCE. The 510(k) number is K260150.

When did LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) receive FDA 510(k) clearance?

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) received FDA 510(k) clearance on 2026-04-22, under 510(k) number K260150.

Who is the listed applicant for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

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

What is the FDA product code for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

The FDA product code for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) 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.

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

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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