# K013259: Portable Non-Contact Tonometer, Model PT100

- Pathway: 510(k) (Traditional)
- Applicant: Leica Microsystems, Inc. O.I.D.
- Decided: Feb 20, 2002 after 142 days
- Product code: HKX (Tonometer, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K181260: MiiS Horus Scope DPT 100 (2019), 1 descendant of its own
- K223739: VS Tabletop Tonometer (2023), 0 descendants of its own

## Indications for use
The PT100 is a hénd held non contact tonometer intended to measure the intraocular pressure of the eye.

Source page: https://510kreport.com/device/K013259
Methodology: https://510kreport.com/methodology