Harmony
Ceiling supported surgical lighting system consisting of one or more vLED lightheads.
1manufacturer
1catalogue number
2510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | FST |
| Device type | Light, Surgical, Fiberoptic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100395 |
| Record published | 2016-09-06 |
| Record revised | 2025-01-31 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-01-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| vLED Surgical Lighting System | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| System TWO LED | Medical Illumination International, Inc | 109 |
| Vu | Medical Illumination International, Inc | 48 |
| Maxx Luxx LED | Avante | 30 |
| VistOR MS LED | Medical Illumination International, Inc | 21 |
| MI Product Line | Medical Illumination International, Inc | 20 |
| Vision LED | Avante | 18 |
| Fiberoptic Cable | Black & Black Surgical, Inc. | 17 |
| MaXcess | Nuvasive, Inc. | 17 |
| Integra® | Integra Lifesciences (Ireland) Limited | 16 |
| Integra® | Integra LifeSciences Production Corporation | 14 |
| Snowden-Pencer | Steris Corporation | 11 |
| Vistor PRO LED | Medical Illumination International, Inc | 10 |
Showing 12 of 85. All products under Light, Surgical, Fiberoptic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100395 | 2010-03-17 |
| K003577 | 2001-01-29 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Steris Corporation | 510(k) number | 2014-11-26 | Class II | Software Design Change | STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently. | 140 units | 2015-07-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.