Identity
- Trade Name
- VivaScope System FDA UDI
- Generic Name
- Scanning laser optical microscope FDA UDI
- Device Name
- The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, and software that captures images of in vivo tissue specimens from the exposed surface of the tissue, through the unstained epithelium and into the superficial supporting stroma. It provides non-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® System does NOT provide automated analysis or diagnosis of the images it produces. It is capable of imaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in the dermis. In addition, it is possible to visualize circulation of blood cells (including both erythrocytes and leukocytes) in capillaries and other small vessels. FDA UDI
- Model / Reference
- 1500, 3000, or both FDA UDI
- Description
- The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, and software that captures images of in vivo tissue specimens from the exposed surface of the tissue, through the unstained epithelium and into the superficial supporting stroma. It provides non-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® System does NOT provide automated analysis or diagnosis of the images it produces. It is capable of imaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in the dermis. In addition, it is possible to visualize circulation of blood cells (including both erythrocytes and leukocytes) in capillaries and other small vessels. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860292000306 FDA UDI
- FDA Product Code
- PSN FDA UDI
- GMDN Term
- Scanning laser optical microscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
No
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
Yes
FDA UDI
Category: Scanning laser optical microscope
VivaScope System by Caliber Imaging & Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scanning laser optical microscope.
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- Affymetrix — Affymetrix, Inc. · Class II
- CONVIVO — Carl Zeiss Meditec AG · Class II
- VivaScope System — Caliber Imaging & Diagnostics, Inc. · Class II
- VivaScope 2500 — Caliber Imaging & Diagnostics, Inc. · Class I
Cleared under the same submission
K180162 also covers:
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
- Caliber Imaging & Diagnostics, Inc.
Sources (1)
- FDA UDI 09a34b16-ef0c-4b0f-ab00-ce177f419e12 35 fields · synced Jun 9, 2026