FDA applicant

Laser Spectrum, Inc.

Chicago, IL5 decisions1984–19860 recalls

FDA records 5 decisions for Laser Spectrum, Inc. (Chicago, IL) from 1984 to 1986: 5 510(k) clearances. Most are in product codes HHR (Laser, Surgical, Gynecologic) and GEX (Powered Laser Surgical Instrument). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Laser Spectrum, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Laser Spectrum, 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 Laser Engineering, Inc. 18 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 Max Medical Technologies Corp. 4 Laser Surgical Systems 3 Laser Associated Sciences, Inc. 2 Laser Dental Innovations 2 Laser Endo Technic 2

Laser Spectrum, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Laser”