Surgical Headlight
A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehead to provide light directly onto the field of vision during a medical or surgical procedure.…
A fiber optic lamp mounted on a headband frame and intended to be situated on the user’s forehead to provide light directly onto the field of vision during a medical or surgical procedure. The light typically consists of a magnifying lens, a reflector, and a fiber optic cable that conveys light from a connected light source.
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 | Gulf Fiberoptics, Inc., United States |
|---|---|
| FDA product code | FST |
| Device type | Light, Surgical, Fiberoptic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Manufacturer |
| 510(k) | K061690 |
| Record published | 2016-09-01 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Lightweight, Single Back Adjustment Headgear | In distribution | |
| Light Weight Single Adjustable Headgear | In distribution | |
| Premium Double Adjustable Headgear | In distribution |
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 |
|---|---|
| K061690 | 2006-09-15 |
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 |
|---|---|---|---|---|---|---|---|
| Gulf Fiberoptics, Inc. | 510(k) number | 2011-05-13 | Not classified | Process control | Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated. | 381 units | 2012-08-28 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-04-09 | Class II | Device Design | The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm’s 510k due to light transmitting fiber material difference. | 169 units | 2013-03-07 |
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.