# K964018: Phacoilluminator - Fiberoptic Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Michael Reynard, M.D.
- Decided: Feb 26, 1997 after 142 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) silicone infusion sleeve: named in the summary without a submission number

## Most influential descendants
- K971750: Welch Allyn Phaco Illuminator (1997), 0 descendants of its own

## Indications for use
Provide illumination at surgical site.

Source page: https://510kreport.com/device/K964018
Methodology: https://510kreport.com/methodology