DeviceClearance

Product code ONE— General, Plastic Surgery

ANTI-WRINKLE (AGING) LIGHT, MODEL AAL

Classification name
Powered Light Based Non-Laser Surgical Instrument
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
7
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code ONE under 21 CFR 878.4810, via openFDA

Market context for product code ONE

FDA has cleared 7 devices under product code ONE between 2010 and 2025, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ONE

Recent clearances under product code ONE

Data sourced from openFDA. This site is unofficial and independent of the FDA.