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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 / January 2026 / K252568

510(k) cleared

New Day Skin Spray

Silk Holdings, Inc. · Jan 23, 2026 · K252568

FDA cleared the New Day Skin Spray from Silk Holdings, Inc. on Jan 23, 2026 under K252568, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Aug 14, 2025. The decision came 162 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 Silk Holdings, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252568?

K252568 is the FDA 510(k) for New Day Skin Spray, submitted by Silk Holdings, Inc.. FDA's decision date was Jan 23, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the New Day Skin Spray?

Silk Holdings, Inc., based in Needham, MA, is the applicant of record for K252568.

How long did the K252568 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Jan 23, 2026, 162 days later.

← All decisions in January 2026