# K032703: Innovatech Straight Laser Probe, Model 420-10

- Pathway: 510(k) (Traditional)
- Applicant: Innovatech Surgical, Inc.
- Decided: Oct 24, 2003 after 52 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: 2 generations back to K954307 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024061: Peregrine Straight Laser Probe, Model PD6000.00, Peregrine Surgical, Ltd. (2003)
- K954307: Gamp & Assoc. Disposable Endoocular Laser Probe, Gamp & Assoc. (1995) Summary page 2.
- K980797: Peregrine Fiber Optic Multi-Function Manipulator, Peregrine Surgical, Ltd. (1998) Summary page 2.

## Indications for use
For photocoagulation during ophthalmic surgery. This device delivers laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

Source page: https://510kreport.com/device/K032703
Methodology: https://510kreport.com/methodology