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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 / June 2026 / K261052

510(k) cleared

LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)

Guangdong Newdermo Biotech Co., Ltd. · Jun 29, 2026 · K261052

FDA cleared the LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) from Guangdong Newdermo Biotech Co., Ltd. on Jun 29, 2026 under K261052, 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 31, 2026. The decision came 90 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: 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 K261052?

K261052 is the FDA 510(k) for LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA), submitted by Guangdong Newdermo Biotech Co., Ltd.. FDA's decision date was Jun 29, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)?

Guangdong Newdermo Biotech Co., Ltd., based in Guangzhou, is the applicant of record for K261052.

How long did the K261052 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Jun 29, 2026, 90 days later.

← All decisions in June 2026

Sources