WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K253086

510(k) cleared

LED Light Therapy Device (Models: SG-FM, SG-FE)

Sunglor Technology Co., Ltd. · Dec 19, 2025 · K253086

FDA cleared the LED Light Therapy Device (Models: SG-FM, SG-FE) from Sunglor Technology Co., Ltd. on Dec 19, 2025 under K253086, 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 Sep 23, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Sunglor Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253073 (LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)).

Questions & Answers

What did FDA clear under K253086?

K253086 is the FDA 510(k) for LED Light Therapy Device (Models: SG-FM, SG-FE), submitted by Sunglor Technology Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Device (Models: SG-FM, SG-FE)?

Sunglor Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253086.

How long did the K253086 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Dec 19, 2025, 87 days later.

← All decisions in December 2025

Sources