# K152996: Molteno3 Glaucoma Implant

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Ophthalmic Products, Inc. (Iop)
- Decided: Dec 17, 2015 after 65 days
- Product code: KYF (Implant, Eye Valve)
- Device class: 2
- Regulation: 21 CFR 886.3920
- 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 K062252 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062252: MOLTENO3, Iop, Inc. (2006) Summary page 4.

## Indications for use
The Molteno3 S-Series glaucoma implant is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

Source page: https://510kreport.com/device/K152996
Methodology: https://510kreport.com/methodology