# K091039: Kowa, FM-600, Model LSS50

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co., Ltd.
- Decided: Aug 7, 2009 after 116 days
- Product code: MYC (Ophthalmoscope, Laser, Scanning)
- Device class: 2
- Regulation: 21 CFR 886.1570
- 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 K880920 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913852: Laser Flare Meter, Kowa Optimed, Inc. (1992) Summary page 1.
- K880920: Laser Flare Cell Meter FC-1000, Kowa Optimed, Inc. (1988) Summary page 1.

## Most influential descendants
- K261255: Kowa FM-600 (2026), 0 descendants of its own

## Indications for use
KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.

Source page: https://510kreport.com/device/K091039
Methodology: https://510kreport.com/methodology