DeviceClearance

Product code QCY— General, Plastic Surgery

SNA-001 Silver Photoparticle Topical Gel

Classification name
Laser Absorbing Particles
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

“Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy.”

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

Market context for product code QCY

FDA has cleared 2 devices under product code QCY between 2018 and 2020, filed by 2 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 QCY

Recent clearances under product code QCY

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