# K190034: REMY Medical Therapy Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Footdocprenur, LLC
- Decided: May 15, 2019 after 128 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The REMY device emits energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. The REMY is intended for use in Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including periungual, subungual, and plantar warts. The REMY is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc., and for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc..

Source page: https://510kreport.com/device/K190034
Methodology: https://510kreport.com/methodology