Laser Peripherals, LLC Family of Bare Laser Fibers— 510(k) K170366

Name: FDA 510(k) clearance K170366
Creator: U.S. Food and Drug Administration
Published: 2017-06-08

Substantially Equivalent

Laser Peripherals, LLC

FDA 510(k) clearance K170366 for Laser Peripherals, LLC Family of Bare Laser Fibers, Substantially Equivalent on 2017-06-08. Applicant: Laser Peripherals, LLC. Device class: 2.

Clearance details

Applicant: Laser Peripherals, LLC
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2017-02-06
Decision date: 2017-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Laser Peripherals, LLC

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K030959 — BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-1002003-04-25
K011207 — LASER PERIPHERALS REUSABLE HOLMIUM FIBER2001-07-24
K992083 — SCATTERFREE LATERAL EMITTING FIBER1999-07-12
K974229 — LS-905 FIBERCHOICE ADAPTER SYSTEM1998-02-10
K972272 — LASER PERIPHERALS HOLMIUM BARE FIBERS1997-07-29

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.