# K981665: Silon Topomat Corneal Topography Image Enhancement Device

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Sciences, Inc.
- Decided: Dec 7, 1998 after 210 days
- Product code: MMQ (Topographer, Corneal, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.1350
- 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 K912032 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912032: Silon (TM) Transparent Wound Dressing, Bio Med Sciences, Inc. (1991) Summary page 1.
- K923150: Silon Transparent Wound Dressings, Bio Med Sciences, Inc. (1992) Summary page 1.
- (no number) SilSoft® Aphakic Extended-Wear Contact Lens: named in the summary without a submission number
- (no number) Fluorescein Dye: named in the summary without a submission number

## Indications for use
For the measurement of the topographical surface of the cornea using rasterstereographic imaging techniques.

Source page: https://510kreport.com/device/K981665
Methodology: https://510kreport.com/methodology