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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 / June 2026 / K260690

510(k) cleared

LumiGlam Laser System (SHE-LSP601-3)

Beijing Sano Laser S&T Development Co.,Ltd · Jun 4, 2026 · K260690

FDA cleared the LumiGlam Laser System (SHE-LSP601-3) from Beijing Sano Laser S&T Development Co.,Ltd on Jun 4, 2026 under K260690, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, 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 3, 2026. The decision came 93 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Beijing Sano Laser S&T Development Co.,Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260690?

K260690 is the FDA 510(k) for LumiGlam Laser System (SHE-LSP601-3), submitted by Beijing Sano Laser S&T Development Co.,Ltd. FDA's decision date was Jun 4, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the LumiGlam Laser System (SHE-LSP601-3)?

Beijing Sano Laser S&T Development Co.,Ltd, based in Beijing, is the applicant of record for K260690.

How long did the K260690 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on Jun 4, 2026, 93 days later.

← All decisions in June 2026