FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.)
K Number: K897040
·
Decision Feb 13, 1990
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
17
Review Days
57
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Basic Information
- Device Name
- LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.)
- K Number
- K897040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Luxar Corp.
- Date Received
- December 18, 1989
- Decision Date
- February 13, 1990
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Luxar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K960475 | MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM | Apr 26, 1996 | Substantially Equivalent |
| K953074 | MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM | Aug 28, 1995 | Substantially Equivalent |
| K945888 | MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM | Jan 27, 1995 | Substantially Equivalent |
| K904068 | LUXAR MODEL LX-20 CO2 LASER | Apr 15, 1991 | Substantially Equivalent |
| K903079 | ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM) | Oct 4, 1990 | Substantially Equivalent |
| K900066 | FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER | Mar 19, 1990 | Substantially Equivalent |
| K896478 | LUXAR MODEL LX-20 MINILASE CO2 LASER | Feb 8, 1990 | Substantially Equivalent |
| K896618 | LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE | Jan 9, 1990 | Substantially Equivalent |
| K896595 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE | Jan 9, 1990 | Substantially Equivalent |
| K896711 | LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE | Jan 9, 1990 | Substantially Equivalent |