# K203130: Ophthalmic Yag Laser System YC-200

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Dec 7, 2020 after 49 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: 7 generations back to K894841 (1989). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192045: Ophthalmic Yag Laser System YC-200, Nidek Co., Ltd. (2019) Summary page 6.
- K021550: Lumenis Selecta Duet, Ellex Medical Pty, Ltd. (2002) Summary page 6.

## Indications for use
The OPHTHALMIC YAG LASER SYSTEM YC-200 consists of a slit lamp and the YAG Laser and is indicated for the performance of posterior capsulotomy, posterior membranectomy, pupillary membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.

Source page: https://510kreport.com/device/K203130
Methodology: https://510kreport.com/methodology