# K032400: Lafaci

- Pathway: 510(k) (Traditional)
- Applicant: Vision Pro, LLC
- Decided: May 7, 2004 after 277 days
- Product code: FYD (Apparatus, Exhaust, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.5070
- 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 K852649 (1985). 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)
- K924732: Porta Plumesafe (TM) 601 Smoke Evacuation System, Buffalo Filter Co., Inc. (1993) Summary page 2.
- K924731: Plumesafe (TM) 1201 Smoke Evacuation System, Buffalo Filter Co., Inc. (1993) Summary page 2.
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 2.
- K935218: Schuco-Vac Model 178, Schuco, Inc. (1994) Summary page 2.
- K963434: Viscous Fluid System, Escalon Trek Medical (1996) Summary page 2.
- K852649: Pressure Regulator/Y Connector, C.R. Bard, Inc. (1985) Summary page 2.
- (no number) Visx Star 3 Plume Evacuation: named in the summary without a submission number
- (no number) Slade LASIK Aspiration Lid Speculum: named in the summary without a submission number
- (no number) Kritzinger-Udegraf LASIK Irrigation Cannula-16 guage: named in the summary without a submission number
- (no number) Gimble-Chayet LASIK Drain: named in the summary without a submission number
- (no number) Melki Lasik Flap Stabilizer: named in the summary without a submission number
- (no number) Maldonado LASIK Posterior Ablation Platform: named in the summary without a submission number
- (no number) Kraff Nasal Solid Blade Speculum: named in the summary without a submission number
- (no number) Whitten LASIK Fixation Ring: named in the summary without a submission number

## Indications for use
The LaFaci Surgical System is intended for use during LASIK procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, comeal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, irrigation, fluid aspiration, and the delivery of micro filtered air to the surgical field.

Source page: https://510kreport.com/device/K032400
Methodology: https://510kreport.com/methodology