# K911808: Gemini Ophthalmic Surgery System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Jun 25, 1991 after 63 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
78 later devices descend from it; 14 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980292: Cataract Liquefracture Device (1998), 59 descendants of its own
- K021566: Infiniti (2002), 50 descendants of its own
- K063583: Alcon Vision System (2008), 36 descendants of its own
- K060366: The Amo Ophthalmic Surgical System (2006), 32 descendants of its own
- K063331: Bausch & Lomb NGX Microsurgical System (2006), 24 descendants of its own

## Recalls of this device
- Jun 2, 2015 · Class II · Z-1940-2015: Insufficient seal on the outside packaging, potentially affecting the sterility of the product.
- Apr 29, 2009 · Not classified · Z-1643-2009: Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.

Source page: https://510kreport.com/device/K911808
Methodology: https://510kreport.com/methodology