FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
K Number: K052979
·
Decision Oct 31, 2005
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
27
Applicant Total
3
Review Days
7
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Basic Information
- Device Name
- 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
- K Number
- K052979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isolux, LLC
- Date Received
- October 24, 2005
- Decision Date
- October 31, 2005
- Product Code
- HBI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HBI | Illuminator, Fiberoptic, Surgical Field | FDA class 2 | General, Plastic Surgery |
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