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Exciplex308nm

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171702

by Clarteis

Identifiers

510(k) Number
K171702 FDA 510(k)
FDA Product Code
FTC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4630 FDA 510(k)
Regulation Number
878.4630 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Exciplex308nm is a dermatological medical device that uses ultraviolet light for treatment purposes. It is designed with similar dimensions and materials as predicate devices cleared under K073066.

The device is manufactured by Clarteis and received FDA 510(k) clearance on October 13, 2017, with the clearance number K171702. It is intended for use in general and plastic surgery applications, with a product code of FTC and device class 2.

Frequently asked questions

What is the Exciplex308nm device used for?

The Exciplex308nm is a dermatological medical device that uses ultraviolet light for treatment purposes in general and plastic surgery applications.

Is the Exciplex308nm a single-use device or can it be reused?

The device data does not specify whether the Exciplex308nm is designed for single-use or multiple uses, as this information is not provided in the regulatory documentation.

What are the dimensions and materials of the Exciplex308nm?

The Exciplex308nm is designed with similar dimensions and materials as predicate devices cleared under K073066, though specific measurements are not detailed in the provided information.

How is the Exciplex308nm supplied and stored?

The device data does not include information about how the Exciplex308nm is supplied or the recommended storage conditions, as these details are not specified in the regulatory documentation.

What is the regulatory status of the Exciplex308nm?

The Exciplex308nm received FDA 510(k) clearance on October 13, 2017, with clearance number K171702, and is classified as a device class 2 with product code FTC.

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: PDF Microsoft Word - 171013_510kSummary.doc, Exciplex308nm — FDA 510 (k) K171702 | MedTracker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Clarteis

Sources (1)

  • FDA 510(k) K171702 24 fields · synced Sep 19, 2026