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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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 2 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)).

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