FDA 510(k)

LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))

K-Number: K261370 · 2026-09-16

ApplicantGuangdong Newdermo Biotech Co., Ltd.

Decision Date2026-09-16

Product CodeNFO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261370. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))?

LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K261370.

When did LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) receive FDA 510(k) clearance?

LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261370.

Who is the listed applicant for LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))?

The FDA 510(k) record lists Guangdong Newdermo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))?

The FDA product code for LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) is NFO.

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.

NCT05336136Custom Non-invasive Ventilation Masks in ChildrenCOMPLETED NCT07843810Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese PatientsNOT_YET_RECRUITING NCT06744790Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory SensorCOMPLETED NCT07086742Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse RateCOMPLETED NCT07524517NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn InfantsRECRUITING 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

Other records listing Guangdong Newdermo Biotech Co., Ltd. as applicant

K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)K260202LED Light Therapy Masks (LumiLips FAC07NA)K223544LED light therapy mask (FM-01, FM-02, FM-03)

Related Devices (Code: NFO)

K262861PureLift Pro MaxXtreem Pulse, LLC K260387SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)Hironic Co., Ltd.K253932FACEGYM Pro Device (HD-109)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260179VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.K252621DeepSkin (DEP100)El Global Trade, 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.