510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181518Substantially Equivalent

Sebacia Microparticles

Sebacia, Inc., Duluth GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181518 is the FDA 510(k) clearance record for Sebacia Microparticles, a class II device, cleared for Sebacia, Inc. on under FDA product code QCY (Laser Absorbing Particles). FDA's definition for product code QCY reads: "Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy". FDA records list one 510(k) clearance for Sebacia, Inc. As of , FDA records show no recalls naming K181518.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QCY Laser Absorbing Particles
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sebacia, Inc. 2905 Premiere Pkwy., Suite 150, Duluth GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QCY

Trailing 12 months

FDA records hold no clearances under product code QCY in the trailing twelve months.

FDA records show no clearances under product code QCY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QCY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260