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Harmony vLED Surgical Lighting System

by Steris Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00724995151478 UDI-DI Date6 Sep 2016ListedStatusListed GUDID: not in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Harmony
Generic Name
Operating room light
Model / Reference
vLED Surgical Lighting System
Primary DI / UDI-DI
00724995151478
510(k) Number
FDA Product Code
FST
GMDN Term
Operating room light
Device Class
Class II
Regulation Number
878.4580
GUDID distribution status
Not in Commercial Distribution

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Over-the-Counter
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No