Identity
- Trade Name
- 1300XSB FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- 300 Watt Xenon Illuminator Used For Surgical Instrument Illumination. FDA UDI
- Model / Reference
- 1300XSB FDA UDI
- Description
- 300 Watt Xenon Illuminator Used For Surgical Instrument Illumination. FDA UDI
Identifiers
- Catalog Number
- 03-1300XSB FDA UDI
- Primary DI / UDI-DI
- 00852350007006 FDA UDI
- 510(k) Number
- K022384 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Endoscopic light source unit, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 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
Yes
FDA UDI
Category: Endoscopic light source unit, line-powered
1300xsb by Isolux, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022384 also covers:
- 1300XSB Xenon Light Source — Medical Illumination International, Inc
- 1300XSB Xenon Light Source — Medical Illumination International, Inc
- 1300XSB Xenon Light Source — Medical Illumination International, Inc
- 1300XSB-SP Xenon Light Source — Medical Illumination International, Inc
- 1300XSB-SP Xenon Light Source — Medical Illumination International, Inc
- 1300XSB-SP Xenon Light Source — Medical Illumination International, 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
- Isolux, LLC
Sources (1)
- FDA UDI f61010eb-05d9-4be9-894a-9426a2b6d8af 38 fields · synced Jun 6, 2026