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K Number
K211265
Device Name
TFX-LT2000 Therapy Light
Manufacturer
ToeFX, Inc.
Date Cleared
2022-11-17

(570 days)

Product Code
PDZ
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The TFX-LT2000 Therapy Light device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the ToeFX, Inc. TFX-LT2000 Therapy Light, a Class II medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The information provided (the FDA clearance letter) focuses on regulatory aspects such as:

  • Confirmation of substantial equivalence to a predicate device.
  • Regulatory class and product code.
  • General controls and compliance requirements for medical devices.
  • Indications for Use statement.

There is no mention of:

  • Specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy).
  • Any performance study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance).

Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study proving the device meets them based on the provided text. The document indicates regulatory clearance based on substantial equivalence, not detailed performance study data.

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.