# K181518: Sebacia Microparticles

- Pathway: 510(k) (Traditional)
- Applicant: Sebacia, Inc.
- Decided: Sep 6, 2018 after 90 days
- Product code: QCY (Laser Absorbing Particles)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 545 ancestors in all.
No later device cites it as a predicate yet.
0 of 546 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153671: Family of CoolGlide Aesthetic Lasers, Cutera, Inc. (2016) Summary page 4.

## Indications for use
Sebacia Microparticles are indicated for use as an accessory to 1064 nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild to moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K181518
Methodology: https://510kreport.com/methodology