# K091915: Fluid Isolation Device

- Pathway: 510(k) (Traditional)
- Applicant: Lenstec, Inc.
- Decided: Oct 27, 2009 after 119 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
Longest line of descent: 2 generations back to K842458 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030957: Perfect Capsule, Milvella Pty., Ltd. (2003) Summary page 2.

## Indications for use
The Lenstec Fluid Isolation Device is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells

Source page: https://510kreport.com/device/K091915
Methodology: https://510kreport.com/methodology