# K030957: Perfect Capsule

- Pathway: 510(k) (Traditional)
- Applicant: Milvella Pty., Ltd.
- Decided: Aug 20, 2003 after 146 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: 1 generation back to K842458 (1984). 5 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874969: Prisma Disposable Kratz Capsule Polisher, Advanced Surgical Products, Inc. (1988) Summary page 2.
- K874974: Prisma Disposable Simcoe Capsule Polisher, Advanced Surgical Products, Inc. (1988) Summary page 2.
- K874985: Prisma Disposable Capsule Polisher, Advanced Surgical Products, Inc. (1988) Summary page 2.
- K842458: Site Simcoe Style I/a Handpiece, Chiron Vision Corp. (1984) Summary page 2.
- K874973: Prisma Disposable Simcoe I/a Cannula, Advanced Surgical Products, Inc. (1988) Summary page 2.
- (no number) Ophthalmic Cannulas: named in the summary without a submission number

## Most influential descendants
- K093210: Aqualase Capsule Wash Tip (2010), 9 descendants of its own
- K112425: Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece (2011), 8 descendants of its own
- K121555: Centurion Vision System (2012), 6 descendants of its own
- K161794: CENTURION Vision System (Active SentryTM) (2017), 3 descendants of its own
- K120912: Infiniti (R) Vision System (2012), 3 descendants of its own

## Indications for use
The Milvella Perfect Capsule is intended for use after phacoemulsification of the natural crystalline lens for the purpose of removing residual cortex and/or epithelial cells, by providing a method for sealed capsule polishing and irrigation.

Source page: https://510kreport.com/device/K030957
Methodology: https://510kreport.com/methodology