Ophthalmic Slit Lamp Microscope
It is an AC-powered slit lamp Bio-microscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the…
It is an AC-powered slit lamp Bio-microscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment
Who Else Makes It
Concentrated in Jiangsu (5), Chongqing (3), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
| Shenzhen Certainn Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Main Meditech Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
| Chongqing SS Medical Equipments Co., Ltd. | Chongqing | Chongqing | Manufacturer | 3 |
| Shanghai Bolan Optical Electric Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
| Gaush Neotech Ltd. | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Chongqing Sunkingdom Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | PUE |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-02 |
| Record revised | 2022-12-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LS-5C | In distribution | |
| LS-7CE | In distribution | |
| LS-7DE | In distribution | |
| LS-7C | In distribution | |
| LS-8A | In distribution | |
| LS-6C | In distribution | |
| LS-8 | In distribution | |
| LS-9D | In distribution | |
| LS-8D | In distribution | |
| LS-3 | In distribution | |
| LS-9CS | In distribution | |
| LS-4 | In distribution | |
| LS-8C | In distribution | |
| LS-7DS | In distribution | |
| LS-5 | In distribution | |
| LS-9 | In distribution | |
| LS-6 | In distribution | |
| LS-7CS | In distribution | |
| LS-9C | In distribution | |
| LS-7 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Headrest | Haag-Streit AG | 16 |
| Microclear | Suzhou Microclear Medical Instruments Co., Ltd. | 4 |
| SYL | Chongqing SS Medical Equipments Co., Ltd. | 3 |
| Illuminix | Illuminix Industries LLC | 3 |
| CM02 | Haag-Streit AG | 2 |
| Ocular Surface Analyzer | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2 |
| CM04 | Haag-Streit AG | 2 |
| CM03 | Haag-Streit AG | 2 |
| Moptim | Shenzhen Certainn Technology Co., Ltd. | 1 |
| RM03 | Haag-Streit AG | 1 |
| Labomed eVO350 5-Step Slit lamp -LED | Labotech Microscopes India Private Limited | 1 |
| Imaging Set | Haag-Streit AG | 1 |
Showing 12 of 27. All products under Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
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.