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The Tracker / September 2026 / K261370

510(k) cleared

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

Guangdong Newdermo Biotech Co., Ltd. · Sep 16, 2026 · K261370

FDA cleared the LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) from Guangdong Newdermo Biotech Co., Ltd. on Sep 16, 2026 under K261370, a traditional 510(k). The device falls under product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 27, 2026. The decision came 142 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Guangdong Newdermo Biotech Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261052 (LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)), K260946 (LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)), K260202 (LED Light Therapy Masks (LumiLips FAC07NA)).

Questions & Answers

What did FDA clear under K261370?

K261370 is the FDA 510(k) for LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)), submitted by Guangdong Newdermo Biotech Co., Ltd.. FDA's decision date was Sep 16, 2026, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))?

Guangdong Newdermo Biotech Co., Ltd., based in Guangzhou, is the applicant of record for K261370.

How long did the K261370 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Sep 16, 2026, 142 days later.

← All decisions in September 2026

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