DeviceClearance

Product code PDZ— General, Plastic Surgery

AF Laser

Classification name
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
19
First cleared
Most recent

FDA classification definition

“For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).”

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

Market context for product code PDZ

FDA has cleared 19 devices under product code PDZ between 2010 and 2026, filed by 18 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 PDZ

Recent clearances under product code PDZ

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