# K063640: Kowa SL-15

- Pathway: 510(k) (Special)
- Applicant: Kowa Co., Ltd.
- Decided: Dec 18, 2006 after 11 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: 1 generation back to K954782 (1995). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954782: Kowa Portable Slit Lamp SL-14 & SL-14B, Kowa Optimed, Inc. (1995) Summary page 2.

## Most influential descendants
- K170470: Digital Eye Anterior Camera (2017), 1 descendant of its own
- K133755: Kowa SL-17 (2014), 1 descendant of its own
- K222372: Kowa SL-19 (2022), 0 descendants of its own
- K193188: MiiS Horus Eye Anterior Camera (2020), 0 descendants of its own
- K100500: PSL Classic Slit Lamp (2010), 0 descendants of its own

## Indications for use
KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and an AC-powered stand.

Source page: https://510kreport.com/device/K063640
Methodology: https://510kreport.com/methodology