Cleared Traditional

K230841 - NailLift (FDA 510(k) Clearance)

Jan 2024
Decision
300d
Days
-
Risk

K230841 is an FDA 510(k) clearance for the NailLift. This device is classified as a Prosthesis, Nail.

Submitted by Jps Corporation (Tokyo, JP). The FDA issued a Cleared decision on January 22, 2024, 300 days after receiving the submission on March 28, 2023.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K230841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2023
Decision Date January 22, 2024
Days to Decision 300 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MQZ - Prosthesis, Nail
Device Class -