WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / December 2025 / K251011

510(k) cleared

Chiavaye Personal Moisturizer

Unipack, LLC · Dec 19, 2025 · K251011

FDA cleared the Chiavaye Personal Moisturizer from Unipack, LLC on Dec 19, 2025 under K251011, a traditional 510(k). The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Apr 1, 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 Unipack, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251011?

K251011 is the FDA 510(k) for Chiavaye Personal Moisturizer, submitted by Unipack, LLC. FDA's decision date was Dec 19, 2025, under product code NUC (Lubricant, Personal).

Who makes the Chiavaye Personal Moisturizer?

Unipack, LLC, based in South Plainfield, NJ, is the applicant of record for K251011.

How long did the K251011 review take?

FDA received the submission on Apr 1, 2025 and issued its decision on Dec 19, 2025, 262 days later.

← All decisions in December 2025