Powered Laser Surgical Instrument

What Is It?

A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. 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.

What Is FDA Product Code GEX?

Powered Laser Surgical Instrument is FDA product code GEX, 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 177 clearances under this code; the FDA took a median of 90 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. 8 were reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 201 recalls under this product code since 2003. 9 were by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Reprocessing Controls (32), Process control (23) and Nonconforming Material/Component (20). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.