FDA applicant

Incisive Technologies, Inc.

San Carlos, CA4 decisions1994–20230 recalls

FDA records 4 decisions for Incisive Technologies, Inc. (San Carlos, CA) from 1994 to 2023: 4 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LFC (Device, Caries Detection). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Incisive Technologies Pty, Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Incisive Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Incisive Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Incisive Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Incisive”

FDA records each applicant name separately; these may or may not be the same firm.

Incisive Surgical, Inc. 5 Incisive, LLC 3 Incisive, Inc. (Formerly Named Incisive, LLC) 1

Incisive Technologies, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Incisive”