Eighteeth
Clinically, Lux-SFT Surgical Headlight is worn on the doctor's head for the lighting of the parts for diagnosis and examination of patients. This device must only be used in hospital…
Clinically, Lux-SFT Surgical Headlight is worn on the doctor’s head for the lighting of the parts for diagnosis and examination of patients. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel and not used in the oxygen-rich environment.
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Taizhou Huangyan Guanhong Plastic Steel Products Factory | Taizhou | Zhejiang | Contract manufacturer | 16 |
| Qibei Technology Co., Limited | Kl | Hong Kong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Chamfond Biotech Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Changzhou Sifary Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | EBA |
| Device type | Light, Surgical Headlight |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4630 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-04-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Wireless Z | In distribution | |
| Wireless Z+ | In distribution | |
| Lux-SFT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spark™ TruColor™ | Metrex Research | 42 |
| zumax | Zumax Medical Co., Ltd. | 42 |
| Light, Surgical Headlight | Black & Black Surgical, Inc. | 40 |
| Endeavour™ TruColor™ XL | Metrex Research | 28 |
| Endeavour™ TruColor™ | Metrex Research | 28 |
| Endeavour™ MD | Metrex Research | 22 |
| Orascoptic – Endeavour XL Headlight System | Metrex Research | 18 |
| Orascoptic – Endeavour TruColor Headlight System | Metrex Research | 18 |
| Orascoptic – Endeavour TruColor XL Headlight System | Metrex Research | 18 |
| Orascoptic – Endeavour Headlight System | Metrex Research | 18 |
| Orascoptic – Spark TruColor Headlight System | Metrex Research | 10 |
| Orascoptic – Spark Headlight System | Metrex Research | 10 |
Showing 12 of 24. All products under Light, Surgical Headlight
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.