HARMONY VLED SURGICAL LIGHTNING SYSTEM— 510(k) K100395

Name: FDA 510(k) clearance K100395
Creator: U.S. Food and Drug Administration
Published: 2010-03-17

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K100395 for HARMONY VLED SURGICAL LIGHTNING SYSTEM, Substantially Equivalent on 2010-03-17. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2010-02-16
Decision date: 2010-03-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K100395

K-number listed on FDA's recall record

Z-0930-2015 — Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.Class II·Terminated·Steris Corporation·20141126

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100395.

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