Topcon
The device is designed to supply electrical power, physical support, structural stability, and positional control for ophthalmic instruments commonly used during general eye examinations or…
The device is designed to supply electrical power, physical support, structural stability, and positional control for ophthalmic instruments commonly used during general eye examinations or treatments. It typically consists of a base, a horizontal tabletop surface, and a static or height-adjustable column that enables vertical positioning of the mounted ophthalmic instrument. The unit is intended to be assembled with the Ophthalmic Chair (models OC-8 or OC-9)
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (1), Shaanxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| 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 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
Record
| Listed by | Antoni Carles SA |
|---|---|
| FDA product code | HMF |
| Device type | Stand, Instrument, Ac-Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1860 |
| Premarket notification | Exempt |
| Record published | 2026-06-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Reliance | Haag-Streit USA, Inc. | 19 |
| AtriCure System Cart | Atricure, Inc. | 19 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 13 |
| Refraction Unit | MDT SP. Z O.O. | 13 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 10 |
| Marco | Takagi Seiko Co., Ltd. | 7 |
| Mckesson | Mckesson Medical-Surgical Inc. | 6 |
| IS-5500 | Topcon Corp. | 5 |
| IS-5000 | Topcon Corp. | 2 |
| KXL System | Avedro, Inc. | 2 |
| IS-6500 | Topcon Corp. | 2 |
| Legion | Alcon Laboratories, Inc. | 1 |
Showing 12 of 19. All products under Stand, Instrument, 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.