# K961380: CPC Probe

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss, Inc.
- Decided: Mar 17, 1997 after 341 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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 K915236 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915236: Iris G-Probe, Iriderm Div. (1994) Summary page 1.

## Indications for use
This device will be used in the same manner as the device mentioned above and will permit the Zeiss Visulas Diode II to be further utilized as a therapeutic ophthalmic laser. It incorporates the same intended uses as the Iris Medical G Probe and specifically is recommended for treating the following eye disease: Glaucoma.

Source page: https://510kreport.com/device/K961380
Methodology: https://510kreport.com/methodology