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Harmony VLED Surgical Lightning System

by Steris Corporation

510(k) K100395

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK100395 Date17 Mar 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0930-2015 FDA Class II initiated 26 Nov 2014

    STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FST
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Harmony VLED Surgical Lightning System is a surgical light device. It is classified as a Light, Surgical, Fiberoptic under FDA device classification.

The system received FDA 510(k) clearance (K100395) on March 17, 2010, and is substantially equivalent to a predicate device. It is intended for use in general and plastic surgery settings as indicated by the advisory committee classification.

Other devices from Steris Corporation

See all devices from Steris Corporation →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Harmony VLED Surgical Lightning System used for?

    The Harmony VLED Surgical Lightning System is intended for use in general and plastic surgery settings as a fiberoptic surgical light to provide illumination during procedures.

  • How is the Harmony VLED Surgical Lightning System supplied and is it reusable?

    The system is supplied as a reusable surgical light device; however, specific components such as light guides or handles may be single-use depending on configuration, but the data provided does not specify disposability of individual parts.

  • What regulatory pathway was used for the Harmony VLED Surgical Lightning System?

    The Harmony VLED Surgical Lightning System received FDA 510(k) clearance (K100395) on March 17, 2010, and was determined to be substantially equivalent to a predicate device.