Product Classification

Device

powered light based non-laser surgical instrument with thermal effect

Regulation Description

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

Definition

A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.

Physical State

The device comes in a wide verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavy with weight more than fifty pounds. It generally has a base station with attachments such as different hand piece(s) and touch tone/display screen or other mechanical buttons for user interactions.

Technical Method

This is a light based Non-Laser device that provides thermal effect including broad spectrum source devices such as Intense Pulse Light (IPL) that uses light energy to cut, destroy, remove or coagulate tissue, generally soft tissue. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

Target Area

The device generally targets skin (including dermis, epidermis) and underlying soft tissue or soft tissue in general.

Regulation Medical Specialty

General & Plastic Surgery

Review Panel

General & Plastic Surgery

Product Code

ONF

Premarket Review

Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)

Submission Type

510(k)