# K082871: Xact Lens Inserter System, Models 6MM, 7MM

- Pathway: 510(k) (Traditional)
- Applicant: Sis Ltd., Surgical Instrument Systems
- Decided: Jul 9, 2009 after 283 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- Device class: 1
- Regulation: 21 CFR 886.4300
- 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 K983129 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983129: Disposable Microstaar Injector (Model Msi-P1), Staar Surgical Co. (1998) Summary page 2.
- K002556: Ceeon Easysert Intraocular Lens Injector, Model Imp-1, Pharmacia & Upjohn Co. (2000) Summary page 2.
- K003768: Monarch II Iol Delivery System, Alcon Research, Ltd. (2001) Summary page 2.

## Indications for use
The xact TM foldable lens inserter is a device intended to fold the AVS 3-piece foldable lens, 6mm or 7mm optic, and assisting in placing it into the capsular bag of the eye to replace the natural crystalline lens during normal small-incision cataract surgery. It provides a small tubular pathway in which the foldable lens can be placed into the eye with a continuous forward motion.

Source page: https://510kreport.com/device/K082871
Methodology: https://510kreport.com/methodology