Cleared Traditional

K241116 - Onycho Laser V

K241116 is an FDA 510(k) clearance for Onycho Laser V, manufactured by Terasysd&C, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PDZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K241116 · Terasysd&C, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
90d
Days
Class 2
Risk

K241116 is an FDA 510(k) clearance for the Onycho Laser V. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Terasysd&C, Inc. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on July 22, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. 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 Terasysd&C, Inc. devices

FDA 510(k) Submission Details - K241116

510(k) Number K241116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2024
Decision Date July 22, 2024
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDZ Device Classification - Class 2, Special Controls

Product Code PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition For The Temporary Increase Of Clear Nail In Patients With Onychomycosis (e.g., Dermatophytes Trichophyton Rubrum And T Mentagrophytes, And/or Yeasts Candida Albicans, Etc.).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

GMSC Co., Ltd.
Kim Jonghyeon

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.

Regulatory Peers - PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

All 10
Devices cleared under the same product code (PDZ) and FDA review panel - the closest regulatory comparables to K241116.
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