FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OptiLux LED Illuminator
K Number: K163185
·
Decision Nov 21, 2016
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
27
Applicant Total
3
Review Days
7
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OptiLux LED Illuminator
- K Number
- K163185
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Isolux, LLC
- Date Received
- November 14, 2016
- Decision Date
- November 21, 2016
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBI), ordered by most recent decision date.
Light-Guide Cables
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KOGENT SPETZLER LIGHTED SUCTION TUBES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGHT GUIDE CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOSCOPIC FIBEROPTIC CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOSCOPIC FIBEROPTIC CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery