Cleared Traditional

K230841 - NailLift (FDA 510(k) Clearance)

K230841 · Jps Corporation · General & Plastic Surgery device
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Jan 2024
Decision
300d
Days
-
Risk

K230841 is an FDA 510(k) clearance for the NailLift. Classified as Prosthesis, Nail (product code MQZ).

Submitted by Jps Corporation (Tokyo, JP). The FDA issued a Cleared decision on January 22, 2024 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Jps Corporation devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 114d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQZ Prosthesis, Nail
Device Class -

Regulatory Consultant

Tech2med, LLC
Kelli Anderson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.