FDA applicant

Sharplan Lasers, Inc.

Allendale, NJ78 decisions1986–19970 recalls

FDA records 78 decisions for Sharplan Lasers, Inc. (Allendale, NJ) from 1986 to 1997: 78 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LNK (Laser For Gastro-Urology Use). Its devices cite 21 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

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 Sharplan Lasers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sharplan Lasers, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sharplan Lasers, 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 “Sharplan”

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

Sharplan Industries, Inc. 4

Sharplan Lasers, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sharplan”