FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VLS 5300 300W XENON LIGHT SOURCE
K Number: K904681
·
Decision Dec 18, 1990
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
27
Applicant Total
5
Review Days
64
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Basic Information
- Device Name
- VLS 5300 300W XENON LIGHT SOURCE
- K Number
- K904681
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Vistek Corp.
- Date Received
- October 15, 1990
- Decision Date
- December 18, 1990
- Product Code
- HBI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
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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