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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 / May 2026 / K260138

510(k) cleared

LUNE PureHygiene

Enamel Pure · May 29, 2026 · K260138

FDA cleared the LUNE PureHygiene from Enamel Pure on May 29, 2026 under K260138, 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 Jan 16, 2026. The decision came 133 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 Enamel Pure in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260138?

K260138 is the FDA 510(k) for LUNE PureHygiene, submitted by Enamel Pure. FDA's decision date was May 29, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the LUNE PureHygiene?

Enamel Pure, based in Worcester, MA, is the applicant of record for K260138.

How long did the K260138 review take?

FDA received the submission on Jan 16, 2026 and issued its decision on May 29, 2026, 133 days later.

← All decisions in May 2026