# K133546: Starlite-OM, Light Effects, Thibiant

- Pathway: 510(k) (Traditional)
- Applicant: Ps Advanced Engineering
- Decided: Aug 6, 2014 after 260 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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: 12 generations back to K943450 (1995). 96 ancestors in all.
No later device cites it as a predicate yet.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120775: Light for Wrinkles, Led Intellectual Properties, LLC (2012) Summary page 4.
- K120560: Trinity Wrinkle Remover, Carol Cole Company (2012) Summary page 4.
- K130225: Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction Device, Silverbay, LLC, D/B/A Quasar Bio-Tech (2013) Summary page 4.
- K092460: Star-Lite -LM, Model SL8809, Ps Advanced Engineering (2010) Summary page 4.

## Indications for use
SL-8813 is an Over The Counter (OTC) handheld device intended for in the treatment of full face wrinkles

Source page: https://510kreport.com/device/K133546
Methodology: https://510kreport.com/methodology