ONE

Powered Light Based Non-Laser Surgical Instrument

Product code

ONE

Device name

Powered Light Based Non-Laser Surgical Instrument

Device class

Class 2

21 CFR

21 CFR 878.4810

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

7 (all years; only the last 3 years are listed here)

FDA classification definition

A light based Non-Laser device typically indicated to be used 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. 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-18.

1 summaries are archived here for direct download.