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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 / K253871

510(k) cleared

Klär Lite (RCW-KL1000)

Radcliffe Watts, LLC · Mar 4, 2026 · K253871

FDA cleared the Klär Lite (RCW-KL1000) from Radcliffe Watts, LLC on Mar 4, 2026 under K253871, a traditional 510(k). The device falls under product code FTC, Light, Ultraviolet, Dermatological, regulated at 21 CFR 878.4630 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 4, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Radcliffe Watts, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253871?

K253871 is the FDA 510(k) for Klär Lite (RCW-KL1000), submitted by Radcliffe Watts, LLC. FDA's decision date was Mar 4, 2026, under product code FTC (Light, Ultraviolet, Dermatological).

Who makes the Klär Lite (RCW-KL1000)?

Radcliffe Watts, LLC, based in Mansfield, OH, is the applicant of record for K253871.

How long did the K253871 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Mar 4, 2026, 90 days later.

← All decisions in March 2026