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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / June 2026 / K260946

510(k) cleared

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)

Guangdong Newdermo Biotech Co., Ltd. · Jun 18, 2026 · K260946

FDA cleared the LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) from Guangdong Newdermo Biotech Co., Ltd. on Jun 18, 2026 under K260946, a traditional 510(k). The device falls under product code OHS, Light Based Over The Counter Wrinkle Reduction, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 23, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Guangdong Newdermo Biotech Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261370 (LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))), K261052 (LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)), K260202 (LED Light Therapy Masks (LumiLips FAC07NA)).

Questions & Answers

What did FDA clear under K260946?

K260946 is the FDA 510(k) for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K), submitted by Guangdong Newdermo Biotech Co., Ltd.. FDA's decision date was Jun 18, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

Guangdong Newdermo Biotech Co., Ltd., based in Guangzhou, is the applicant of record for K260946.

How long did the K260946 review take?

FDA received the submission on Mar 23, 2026 and issued its decision on Jun 18, 2026, 87 days later.

← All decisions in June 2026

Sources