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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 / February 2026 / K253002

510(k) cleared

SkinStylus SteriLock MicroSystem (MP1209SL)

Esthetic Medical, Inc. · Feb 19, 2026 · K253002

FDA cleared the SkinStylus SteriLock MicroSystem (MP1209SL) from Esthetic Medical, Inc. on Feb 19, 2026 under K253002, a traditional 510(k). The device falls under product code QAI, Powered Microneedle Device, regulated at 21 CFR 878.4430 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 19, 2025. The decision came 153 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 Esthetic Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253002?

K253002 is the FDA 510(k) for SkinStylus SteriLock MicroSystem (MP1209SL), submitted by Esthetic Medical, Inc.. FDA's decision date was Feb 19, 2026, under product code QAI (Powered Microneedle Device).

Who makes the SkinStylus SteriLock MicroSystem (MP1209SL)?

Esthetic Medical, Inc., based in Long Beach, CA, is the applicant of record for K253002.

How long did the K253002 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Feb 19, 2026, 153 days later.

← All decisions in February 2026