FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUXTEC LIGHT SOURCES
K Number: K864385
·
Decision Jan 13, 1987
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
30
Applicant Total
15
Review Days
69
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Basic Information
- Device Name
- LUXTEC LIGHT SOURCES
- K Number
- K864385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Luxtec Corp.
- Date Received
- November 5, 1986
- Decision Date
- January 13, 1987
- Product Code
- FCW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCW | Light Source, Fiberoptic, Routine | FDA class 2 | Gastroenterology, Urology |
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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 |
| K864865 | SPECULUM, VAGINAL, METAL FIBEROPTIC | Jan 9, 1987 | Substantially Equivalent |