QCY · Class II · 21 CFR 878.4810

FDA Product Code QCY: Laser Absorbing Particles

Particles Are Applied To The Target Tissue(s) For The Purpose Of Absorbing Laser/light Energy.

Leading manufacturers include Sebacia, Inc. and Sienna Biopharmaceuticals, Inc..

2
Total
2
Cleared
207d
Avg days
2018
Since

FDA 510(k) Cleared Laser Absorbing Particles Devices (Product Code QCY)

2 devices
1–2 of 2
Cleared Aug 12, 2020
SNA-001 Silver Photoparticle Topical Gel
K192620
Sienna Biopharmaceuticals, Inc.
General & Plastic Surgery · 324d
Cleared Sep 06, 2018
Sebacia Microparticles
K181518
Sebacia, Inc.
General & Plastic Surgery · 90d

About Product Code QCY - Regulatory Context