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dpl II Panel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171390

by Led Technologies, Inc.

Identifiers

510(k) Number
K171390 FDA 510(k)
FDA Product Code
OHS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The dpl II Panel is a light-based over-the-counter wrinkle reduction device. It is a Class II medical device manufactured by Led Technologies, Inc. for use in general and plastic surgery applications.

The device is supplied as a panel and is intended for at-home use. It received FDA 510(k) clearance on August 3, 2017, with the clearance number K171390. The device is regulated under product code OHS and regulation number 878.4810.

Frequently asked questions

What is the dpl II Panel used for?

The dpl II Panel is a light-based over-the-counter medical device designed for wrinkle reduction. It is intended for at-home use and is suitable for general and plastic surgery applications to help reduce the appearance of wrinkles.

How is the dpl II Panel supplied?

The device is supplied as a panel unit designed for convenient at-home use. It comes ready for operation with all necessary components included for wrinkle reduction treatments.

What is the regulatory status of the dpl II Panel?

The dpl II Panel is a Class II medical device that received FDA 510(k) clearance on August 3, 2017, with clearance number K171390. It is regulated under product code OHS and regulation number 878.4810.

Is the dpl II Panel reusable or single-use?

The device is designed for repeated use rather than single-use. As a Class II medical device for at-home wrinkle reduction, it is built to be used multiple times following the manufacturer's instructions for proper care and maintenance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: dpl II Panel: FDA Clearance & Evidence Check | SkinCarisma, dpl II Panel — FDA 510 (k) K171390 | MedTracker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Led Technologies, Inc.

Sources (1)

  • FDA 510(k) K171390 24 fields · synced Sep 27, 2026