# K946054: Diplomax

- Pathway: 510(k) (Traditional)
- Applicant: Optical Micro Systems, Inc.
- Decided: Jul 11, 1995 after 211 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.
62 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K981116: Sovereign Cataract Extraction System (1998), 59 descendants of its own
- K021566: Infiniti (2002), 50 descendants of its own
- K063583: Alcon Vision System (2008), 36 descendants of its own
- K063331: Bausch & Lomb NGX Microsurgical System (2006), 24 descendants of its own
- K082845: Infiniti Vision System with Ozil IP (2009), 22 descendants of its own

Source page: https://510kreport.com/device/K946054
Methodology: https://510kreport.com/methodology