FDA applicant

Laser Engineering, Inc.

Milford, MA18 decisions1988–20220 recalls

FDA records 18 decisions for Laser Engineering, Inc. (Milford, MA) from 1988 to 2022: 18 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HHR (Laser, Surgical, Gynecologic). Its devices cite 2 predicates, 1 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 Laser Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Laser Engineering, 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 “Laser”

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

Laser Industries, Ltd. 20 L.A.S.E.R., Inc. 14 Laser Photonics, Inc. 14 Laser Media 13 Laser Peripherals, LLC 12 Laser-Optik-Systeme GmbH & Co. KG 7 Laser Spectrum, Inc. 5 Laser Max Medical Technologies Corp. 4 Laser Surgical Systems 3 Laser Associated Sciences, Inc. 2 Laser Dental Innovations 2 Laser Endo Technic 2

Laser Engineering, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Laser”