# K043613: Q-Switched ND:Yag Ophtalmic Laser (with Slit Lamp), Model Optimis II

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Mar 24, 2005 after 84 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
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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K992824: Laserex ND:Yag Ophthalmic Laser (LQ2106), Alcon ND:Yag Ophthalmic Laser (3000LE), Laserex ND:Yag Ophthalmic Laser, Model, Ellex Medical Pty, Ltd. (1999). Our reading of the summary gave K992824, FDA’s number for Laserex ND:Yag Ophthalmic Laser (LQ2106), Alcon ND:Yag… (Ellex Medical Pty, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “AURAT (Coherent)”. Kept off the family tree. Summary page 1.

## Indications for use
The 'Optimis II Q-Switched Nd:YAG Photodisruptor is intended for posterior capsulotomy.

Source page: https://510kreport.com/device/K043613
Methodology: https://510kreport.com/methodology