Powered Laser Surgical Instrument With MicrobeamFractional Output

What Is It?

A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue.

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, remove or coagulate tissue by the light.

How Is ONG Classified?

Powered Laser Surgical Instrument With MicrobeamFractional Output is FDA product code ONG, Class 2, 21 CFR 878.4810.

What Does It Take to Sell It in the United States?

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 5 clearances under this code; the FDA took a median of 114 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 4 recalls under this product code since 2010. 1 was by a company in China. The root causes the FDA records most often are Radiation Control for Health and Safety Act (2), Software design (1) and Labeling Change Control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.