# K073010: Royale AE 9036 LSP Injector

- Pathway: 510(k) (Traditional)
- Applicant: Asico, LLC
- Decided: Nov 7, 2007 after 13 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023737: Injector, Anton Meyer & Co., Ltd. (2003) Summary page 1.
- K003768: Monarch II Iol Delivery System, Alcon Research, Ltd. (2001) Summary page 1.
- K011392: Micra Lens Injector, Micra Cartridge Lens, Micra Lens Loader, Micra Instruments (2001) Summary page 1.

## Indications for use
The Royalee AE-9036 LSP Injectors are reusable instruments to assist in Implanting Alcon ACRYSOF ® foldable intraocular lenses during a normal small incision cataract surgery. They are designed to incorporate Monarch III cartridges D and Monarch II cartridge C for foldable intraocular lenses. The cartridges are loaded into the injector body. By pushing the piston, the lens-will be removed out of the cartridge and delivered to the desired position.

Source page: https://510kreport.com/device/K073010
Methodology: https://510kreport.com/methodology