# K143434: One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Medical Optics, Inc.
- Decided: May 6, 2015 after 156 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: 3 generations back to K930320 (1994). 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)
- K081545: One Series Ultra Cartridge, Model 1VIPR30, Advanced Medical Optics, Inc. (2008) Summary page 5.

## Indications for use
Either the DK7786 or DK7791 handpiece is used in combination with the ONE SERIES Ultra Cartridge, Model 1VIPR30 to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag. The Model DK7796 handpiece is used in combination with the Model IMTEC30 cartridge to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag.

Source page: https://510kreport.com/device/K143434
Methodology: https://510kreport.com/methodology