Identity
- Trade Name
- LEISEGANG FDA UDI
- Generic Name
- Colposcope FDA UDI
- Device Name
- OPTIK Model 2 Colposcope; Integrated Analog Video Upright Scope with LCD FDA UDI
- Model / Reference
- OPTIK2-11-001 FDA UDI
- Description
- OPTIK Model 2 Colposcope; Integrated Analog Video Upright Scope with LCD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937013122 FDA UDI
- 510(k) Number
- K940094 FDA UDI
- FDA Product Code
- HEX FDA UDI
- GMDN Term
- Colposcope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colposcope
Leisegang by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colposcope.
- MICROSCOPE Colposcope — Ecleris · Class II
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- MICROSTAR Colposcope — Ecleris · Class II
- Gynex — GYNEX CORPORATION · Class II
- MICROSCOPE Colposcope — Ecleris · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Galileo Colposcope, Direct Access — GYNEX CORPORATION · Class II
Cleared under the same submission
K940094 also covers:
- LEISEGANG — CooperSurgical, Inc.
- LEISEGANG — CooperSurgical, Inc.
- LEISEGANG — CooperSurgical, Inc.
- LEISEGANG — CooperSurgical, Inc.
- LEISEGANG — CooperSurgical, Inc.
- LEISEGANG — CooperSurgical, Inc.
- LEISEGANG — CooperSurgical, Inc.
- LEISEGANG — CooperSurgical, Inc.
- LEISEGANG OptiK® Model 2 Colposcope — CooperSurgical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI a5e0fd91-9829-4a29-920b-418a4a853ec3 34 fields · synced Jun 9, 2026