Luxor
LUXOR Opthalmic Microscope Footswitch
12manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Guangxi (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Shenzhen Certainn Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Suzhou Raish Meditech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | HRM |
| Device type | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Premarket notification | Exempt |
| Record published | 2020-08-31 |
| Record revised | 2024-03-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2022-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8065752566 | In distribution | |
| 00380657525706 | In distribution | |
| 00380657525607 | In distribution | |
| 00380657525683 | In distribution | |
| 00380657530625 | In distribution | |
| 00380657530656 | In distribution | |
| 00380657530632 | Withdrawn | |
| 00380657525676 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Inami | Inami & Co., Ltd. | 9 |
| Unbranded | Advance Medical Designs, Inc. | 8 |
| Procam HD 2D | Ecleris SRL | 5 |
| Unity | Alcon Laboratories, Inc. | 4 |
| Dovetail for Biom | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 4 |
| Inverter Vitrectomy System Set For Leica Type Microscopes | Ocular Instruments, Inc. | 4 |
| Optomic | Optomic España SA | 3 |
| Moptim | Shenzhen Certainn Technology Co., Ltd. | 3 |
| LuxOR Revalia | Alcon Laboratories, Inc. | 3 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 3 |
| Microscope Cover Leica 137/380 7.00 HLT | Pharma Sept Medical Products (1995) Ltd. | 3 |
| Inverter Vitrectomy System Set For Zeiss Type Microscopes | Ocular Instruments, Inc. | 3 |
Showing 12 of 152. All products under Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K920641 | 1992-10-09 |
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.