Lutech
High definition digital video colposcope.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Goldcare Meditech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou | Jiangsu | Contract manufacturer | 7 |
| Beijing Tech Instrument Co., Ltd. | Chongwen District | Beijing | Manufacturer | 1 |
Record
| Listed by | Waverly Life Sciences LLC |
|---|---|
| FDA product code | HEX |
| Device type | Colposcope (And Colpomicroscope) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1630 |
| 510(k) | K170446 |
| Record published | 2017-06-29 |
| Record revised | 2025-03-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LT-300 SD | In distribution | |
| LT-300 HD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leisegang | Coopersurgical, Inc. | 17 |
| Microscope Colposcope | Ecleris SRL | 16 |
| Bovie | Aspen Surgical Products, Inc. | 15 |
| Henry Schein | Henry Schein, Inc. | 15 |
| Galileo Colposcope, Direct Access | Gynex Corporation | 11 |
| Microstar Colposcope | Ecleris SRL | 11 |
| Wallach | Coopersurgical, Inc. | 7 |
| Kernel | Xuzhou Kernel Medical Equipment Co Ltd | 6 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Unico ColpoMaster I | United Products & Instruments, Inc. | 4 |
| Gynex | Gynex Corporation | 4 |
| medgyn video colposcope | Medgyn Products, Inc. | 3 |
Showing 12 of 42. All products under Colposcope (And Colpomicroscope)
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.