# K162636: Marco Ultra M3, Marco Ultra M4

- Pathway: 510(k) (Traditional)
- Applicant: Takagi Seiko Co., Ltd.
- Decided: Apr 14, 2017 after 205 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K982057 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100202: Slit Lamp BO 900, BQ 900, BP900, Haag-Streit AG (2010) Summary page 5.
- K152535: Z5 Slit lamp microscope, Z2 Slit lamp microscope, Takagi Seiko Co., Ltd. (2016) Summary page 5.

## Indications for use
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.

Source page: https://510kreport.com/device/K162636
Methodology: https://510kreport.com/methodology