FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER
K Number: K900066
·
Decision Mar 19, 1990
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
17
Review Days
74
Basic Information
- Device Name
- FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER
- K Number
- K900066
- 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
- January 4, 1990
- Decision Date
- March 19, 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 |
| K897040 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.) | Feb 13, 1990 | Substantially Equivalent |
| K896478 | LUXAR MODEL LX-20 MINILASE CO2 LASER | Feb 8, 1990 | Substantially Equivalent |
| K896619 | LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE | Jan 9, 1990 | Substantially Equivalent |
| K896711 | LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE | Jan 9, 1990 | Substantially Equivalent |
| K896618 | LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE | Jan 9, 1990 | Substantially Equivalent |