FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM
K Number: K864381
·
Decision Dec 9, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
2
Applicant Total
15
Review Days
34
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Basic Information
- Device Name
- LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM
- K Number
- K864381
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Luxtec Corp.
- Date Received
- November 5, 1986
- Decision Date
- December 9, 1986
- Product Code
- FWC
- 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 |
|---|---|---|---|
| FWC | Camera, Television, Surgical, With Audio | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWC), ordered by most recent decision date.
BR-S601MU (SURGICAL VIDEO RECORDER)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KY-M280U SURGICAL CAMERA
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Luxtec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973193 | LUXSCOPE | Nov 21, 1997 | Substantially Equivalent |
| K970642 | TENOSCOPE | May 21, 1997 | Substantially Equivalent |
| K970562 | TENOSNARE | May 14, 1997 | Substantially Equivalent |
| K950960 | REDDY ILLUMINATOR | Sep 8, 1995 | Substantially Equivalent |
| K895248 | IMS5000 ILLUMINATED LOUPES | Sep 15, 1989 | Substantially Equivalent |
| K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE | Apr 26, 1989 | Substantially Equivalent |
| K864387 | LUXTEC FIBEROPTIC CABLES | May 22, 1987 | Substantially Equivalent |
| K864383 | LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS | Jan 14, 1987 | Substantially Equivalent |
| K864382 | FRAZIER SUCTION TUBE | Jan 14, 1987 | Substantially Equivalent |
| K864385 | LUXTEC LIGHT SOURCES | Jan 13, 1987 | Substantially Equivalent |