Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

What Is It?

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.

What Is FDA Product Code ONF?

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect is FDA product code ONF, Class 2, 21 CFR 878.4810.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 26 clearances under this code; the FDA took a median of 110 days from receipt to decision on them.

2 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.