Leica Keratoscope
Leica Keratoscope - Accessory for Leica surgical operating microscope systems
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Leica Microsystems (Schweiz) AG, Switzerland |
|---|---|
| FDA product code | HLQ |
| Device type | Keratoscope, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1350 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-25 |
| Record revised | 2026-01-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2026-01-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000000000010448558 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Auto REF/Keratometer | Nidek Incorporated | 2 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 2 |
| Ibex Keratometer | Trevi Technology | 1 |
| Park 1 | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Refractive Power / Corneal Analyzer | Nidek Incorporated | 1 |
| Medmont Corneal Topographer E300 USB | Medmont International PTY Ltd | 1 |
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.