# K191933: COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal

- Pathway: 510(k) (Special)
- Applicant: Johnson & Johnson Surgical Vision, Inc.
- Decided: Aug 16, 2019 after 28 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.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN110009: Foot Wrap For Treating Restless Leg Syndrome Symptoms. Our reading of the summary gave K113155, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110009, Foot Wrap For Treating Restless Leg Syndrome Symptoms (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
The COMPACT INTUITIV™ System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Source page: https://510kreport.com/device/K191933
Methodology: https://510kreport.com/methodology