# K112880: Clearpath DS-120(R) Lens Fluorescence Biomicroscope

- Pathway: 510(k) (Traditional)
- Applicant: Freedom Meditech, Inc.
- Decided: Jan 31, 2013 after 489 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: 5 generations back to K871268 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102492: P200MAAF, Optos Plc. (2010) Summary page 1.

## Indications for use
The ClearPath DS-1200 Lens Fluorescence Biomicroscope is indicated for use to detect autofluorescence of the crystalline lens.

Source page: https://510kreport.com/device/K112880
Methodology: https://510kreport.com/methodology