# K151337: Strialite

- Pathway: 510(k) (Traditional)
- Applicant: Centre Light Solutions, LLC
- Decided: Feb 24, 2016 after 281 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: 5 generations back to K904627 (1991). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam), Candela Corp. (2002) Summary page 4.

## Indications for use
Strialite is an over-the-counter device indicated for use in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance

Source page: https://510kreport.com/device/K151337
Methodology: https://510kreport.com/methodology