510(k) Report

FDA applicant

Laser Peripherals, LLC

Minnetonka, MN12 decisions1988–20171 recall

FDA records 12 decisions for Laser Peripherals, LLC (Minnetonka, MN) from 1988 to 2017: 12 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HHR (Laser, Surgical, Gynecologic). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Peripherals, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Laser Peripherals, LLC’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.