Labomed Prima OPH Microscope (Motorized Fine Focus & X-Y Coupling)
- MaxLite(TM) optics, 5 step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x - RedReflex optical system - 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply - 45°…
– MaxLite(TM) optics, 5 step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x – RedReflex optical system – 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply – 45° inclined binocular head, IPD 55-75mm – f=200mm CMO – WF 10x/16mm eyepieces with diopter lock and foldable eyeguard – Swivel arm (525mm Long, 360° rotation) and suspension arm (600mm Long, 320° rotation) with locking/tension control knobs and LED shut-off in park position – Motorized carrier with XY reset button; foot pedal with joystick to control XY; up/down pedals to control fine focus – Floor stand with H-shape base on castor wheels with brakes – Blue and Green sliding filters, dust cover, and sterilizable knob caps
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 | Labotech Microscopes India Private Limited, India |
|---|---|
| FDA product code | HRM |
| Device type | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-15 |
| Record revised | 2026-07-20 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-09-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6135000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Inami | Inami & Co., Ltd. | 9 |
| Luxor | Alcon Laboratories, Inc. | 8 |
| 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 |
Showing 12 of 152. All products under Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
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.