510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QCYClass II

Laser Absorbing Particles

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

QCY is the FDA product code for Laser Absorbing Particles, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QCY
Device name
Laser Absorbing Particles
FDA definition
Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy.
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QCY

By decision year
2 clearances under product code QCY with a decision year between 2018 and 2020, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QCY by decision year
YearClearances
20181
20201

Applicants with the most clearances

Product code QCY
Applicants holding the most 510(k) clearances under product code QCY
ApplicantClearances
Sebacia, Inc.1
Sienna Biopharmaceuticals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code