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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 / K251308

510(k) cleared

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

Thera B Medical Products · Jan 15, 2026 · K251308

FDA cleared the SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) from Thera B Medical Products on Jan 15, 2026 under K251308, a traditional 510(k). The device falls under product code LBI, Unit, Neonatal Phototherapy, regulated at 21 CFR 880.5700 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Apr 28, 2025. The decision came 262 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 Thera B Medical Products in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251308?

K251308 is the FDA 510(k) for SnugLit(TM) Wearable Phototherapy System (SNGL-01-US), submitted by Thera B Medical Products. FDA's decision date was Jan 15, 2026, under product code LBI (Unit, Neonatal Phototherapy).

Who makes the SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)?

Thera B Medical Products, based in East Lansing, MI, is the applicant of record for K251308.

How long did the K251308 review take?

FDA received the submission on Apr 28, 2025 and issued its decision on Jan 15, 2026, 262 days later.

← All decisions in January 2026