FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUTEX HEADLIGHT SYSTEMS
K Number: K864380
·
Decision Nov 19, 1986
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
44
Applicant Total
15
Review Days
14
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Basic Information
- Device Name
- LUTEX HEADLIGHT SYSTEMS
- K Number
- K864380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Luxtec Corp.
- Date Received
- November 5, 1986
- Decision Date
- November 19, 1986
- Product Code
- FST
- 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 |
|---|---|---|---|
| FST | Light, Surgical, Fiberoptic | FDA class 2 | General, Plastic Surgery |
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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 |