# K990075: Lpulsa Syl-9000 Ophthalmic Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Light-Med (Usa), Inc.
- Decided: Mar 30, 1999 after 78 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Nov 11, 2003 · Not classified · Z-0228-04: Firm needed to include calibration procedures in user guide.

## Indications for use
Posterior Capsulotomy Pupillary Membranectomy

Source page: https://510kreport.com/device/K990075
Methodology: https://510kreport.com/methodology