Leisegang
The Cooper Surgical Leisegang Colposcope Systems are optical colposcopes for non-contact viewing of tissues in the cervix, vulva, vagina and anogenital areas. The filing says the systems…
The Cooper Surgical Leisegang Colposcope Systems are optical colposcopes for non-contact viewing of tissues in the cervix, vulva, vagina and anogenital areas. The filing says the systems provide magnified viewing to assist doctors in assessing abnormalities and selecting areas for biopsy.
The filing describes images from the colposcope systems as viewable through the system’s video components. Specific equipment and modes depend on the model or mode selected, so those details are not attributed here to every Leisegang configuration.
Listed Item
OPTIK Model 2 Colposcope; 3 MAG 0.5″ CCD Optimized Photo Swing Scope with Infinity Camera
Viewing Function
The FDA document describes the system as supporting magnified examination of the listed tissues. It frames the purpose as assisting doctors in diagnosis and biopsy-area selection; it does not establish a diagnosis or outcome for an individual patient.
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 | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | HEX |
| Device type | Colposcope (And Colpomicroscope) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1630 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K140754 |
| Record published | 2016-07-29 |
| Record revised | 2024-02-28 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | serial number |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OPTIK1-02 | In distribution | |
| OPTIK2-12 | In distribution | |
| OPTIK1-00 | In distribution | |
| OPTIK2-05-002 | In distribution | |
| OPTIK2-06-005 | In distribution | |
| OPTIK1-01 | In distribution | |
| OPTIK2-10 | In distribution | |
| OPTIK2-11-001 | In distribution | |
| OPTIK2-04-002 | In distribution | |
| OPTIK1-03 | In distribution | |
| OPTIK2-03-002 | In distribution | |
| OPTIK2-11 | In distribution | |
| OPTIK2-10-001 | In distribution | |
| OPTIK2-12-001 | In distribution | |
| OPTIK2-03 | Withdrawn | |
| OPTIK2-05 | Withdrawn | |
| OPTIK2-04 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| MedGyn Gynescope | Medgyn Products, Inc. | 3 |
Showing 12 of 42. All products under Colposcope (And Colpomicroscope)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140754 | 2014-10-23 |
| K972630 | 1998-02-02 |
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.