# K971186: Amo Diplomax/Opsys Console

- Pathway: 510(k) (Traditional)
- Applicant: Allergan, Inc.
- Decided: Jun 13, 1997 after 73 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.
60 later devices descend from it; 1 cites it directly.
0 of 61 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) AMO®Diplomax™ console: named in the summary without a submission number
- (no number) AMO®Opsys® console: named in the summary without a submission number

## 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

## Indications for use
The AMO®Diplomax™ and AMO®Opsys® consoles are components of phacofragmentation systems designed to provide all the surgical capabilities desired by the Anterior Segment/Cataract Surgeon. Phacofragmentation, also known as phacoemulsification or “phaco,” is a cataract removal technique. When utilizing this technique, the surgeon makes a small incision in the eye and breaks up the cataract using ultrasonic vibration delivered by the tip of the handpiece inserted through the incision.

Source page: https://510kreport.com/device/K971186
Methodology: https://510kreport.com/methodology