# K170591: Altomed Malhotra Platinum Segments

- Pathway: 510(k) (Traditional)
- Applicant: Altomed Limited
- Decided: Jun 6, 2017 after 98 days
- Product code: MML (Weights, Eyelid, External)
- Device class: 2
- Regulation: 21 CFR 886.5700
- 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 K011115 (2001). 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)
- K011115: Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010, Heinz Kurz GmbH Medizintechnik (2001) Summary page 4.

## Indications for use
Malhotra Platinum Segments are eyelid implants designed for the gravity-assisted treatment of lagophthalmos.

Source page: https://510kreport.com/device/K170591
Methodology: https://510kreport.com/methodology