# K180402: PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Laser Systems, Inc.
- Decided: May 25, 2018 after 100 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894841 (1989). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171488: PSLT for PASCAL Streamline, Topcon Medical Laser Systems, Inc. (2017) Summary page 4.

## Indications for use
Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Synthesis and PASCAL Synthesis TwinStar for procedures in trabeculoplasty in open angle glaucoma.

Source page: https://510kreport.com/device/K180402
Methodology: https://510kreport.com/methodology