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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 / March 2026 / K260202

510(k) cleared

LED Light Therapy Masks (LumiLips FAC07NA)

Guangdong Newdermo Biotech Co., Ltd. · Mar 23, 2026 · K260202

FDA cleared the LED Light Therapy Masks (LumiLips FAC07NA) from Guangdong Newdermo Biotech Co., Ltd. on Mar 23, 2026 under K260202, 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 Jan 23, 2026. The decision came 59 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)), K260946 (LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)).

Questions & Answers

What did FDA clear under K260202?

K260202 is the FDA 510(k) for LED Light Therapy Masks (LumiLips FAC07NA), submitted by Guangdong Newdermo Biotech Co., Ltd.. FDA's decision date was Mar 23, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Masks (LumiLips FAC07NA)?

Guangdong Newdermo Biotech Co., Ltd., based in Guangzhou, is the applicant of record for K260202.

How long did the K260202 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Mar 23, 2026, 59 days later.

← All decisions in March 2026

Sources