FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILLUMINATOR IV MINOR SURGERY LIGHT
K Number: K922279
·
Decision Sep 2, 1992
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
7
Applicant Total
10
Review Days
110
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Basic Information
- Device Name
- ILLUMINATOR IV MINOR SURGERY LIGHT
- K Number
- K922279
- 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
- Medical Illumination, Inc.
- Date Received
- May 15, 1992
- Decision Date
- September 2, 1992
- Product Code
- FSW
- 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 |
|---|---|---|---|
| FSW | Light, Surgical, Endoscopic | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Medical Illumination, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931026 | MI-5 DIAGNOSTIC LIGHT | Aug 19, 1993 | Substantially Equivalent |
| K931646 | MI-4 VARIABLE SPOT LIGHT | Aug 19, 1993 | Substantially Equivalent |
| K930897 | MI-15 EXAM SURGICAL LIGHT | Jun 25, 1993 | Substantially Equivalent |
| K925710 | M.E.D. LIGHT | Jun 4, 1993 | Substantially Equivalent |
| K922278 | ILLUMINATOR III | Mar 4, 1993 | Substantially Equivalent |
| K922282 | ILLUMINATOR VIII ULTRA/SPOT | Mar 4, 1993 | Substantially Equivalent |
| K922281 | ILLUMINATOR VII MINI/SPOT LIGHT | Feb 5, 1993 | Substantially Equivalent |
| K922280 | ILLUMINATOR VII MINI/LUM LIGHT | Feb 5, 1993 | Substantially Equivalent |
| K922277 | ILLUMINATOR II | Feb 5, 1993 | Substantially Equivalent |