Onycho Laser V
510(k) K241116
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241116 | Date22 Jul 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- PDZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Onycho Laser V is a Laser for Temporary Increase of Clear Nail in Patients with Onychomycosis, classified as a Class 2 device under FDA regulation 878.4810. This device employs non-thermal low-level laser therapy to target fungal infections in nails, aiming to improve nail clarity without the side effects associated with oral antifungal medications. Its design aligns with voluntary standards for electrical safety and electromagnetic compatibility, ensuring reliable performance in clinical settings.
The Onycho Laser V is supplied as a reusable medical device, intended for use in outpatient or clinical environments by trained professionals. It adheres to FDA clearance (K241116) under the Traditional 510(k) pathway, with no explicit mention of MRI safety or sterility requirements in the provided data. Storage and handling instructions are not detailed, but compliance with electrical safety standards is confirmed. The device is regulated under the General, Plastic Surgery advisory committee and falls under product code PDZ.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Onycho Laser V, and how does it differ from oral antifungal treatments for onychomycosis?
The Onycho Laser V is designed to temporarily improve nail clarity in patients with onychomycosis (fungal nail infections) using non-thermal low-level laser therapy. Unlike oral antifungals, which target systemic fungal infections and may cause side effects, this device focuses on the nail itself without systemic exposure, aiming to enhance appearance without the potential risks of oral medications.
Is the Onycho Laser V intended for single-use or repeated clinical use, and what are the key considerations for its maintenance?
The Onycho Laser V is classified as a reusable medical device, meaning it is meant for use in outpatient or clinical settings by trained professionals over multiple procedures. While the data does not specify sterility requirements or detailed cleaning protocols, compliance with electrical safety and electromagnetic compatibility standards ensures reliable performance. Proper handling and adherence to manufacturer guidelines for reuse are critical to maintain functionality and safety.
What regulatory pathway was followed for FDA clearance of the Onycho Laser V, and which advisory committee reviewed its submission?
The Onycho Laser V received FDA clearance (K241116) under the Traditional 510(k) pathway, determined to be substantially equivalent to a predicate device. Its submission was reviewed by the General, Plastic Surgery advisory committee, reflecting its classification under product code PDZ and its intended use in nail-related treatments. This pathway ensures the device meets safety and effectiveness standards for Class 2 medical devices.
Are there any specific storage instructions provided for the Onycho Laser V, or should it be stored under particular conditions?
The provided data does not include explicit storage instructions for the Onycho Laser V. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its electrical and operational integrity. Adherence to general electrical safety standards is implied, but users should refer to the manufacturer’s guidelines for precise storage recommendations.