FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLT DIFFUSER FIBER
K Number: K010041
·
Decision Mar 7, 2001
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
51
Review Days
61
Basic Information
- Device Name
- SLT DIFFUSER FIBER
- K Number
- K010041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SURGICAL LASER TECHNOLOGIES, INC.
- Date Received
- January 5, 2001
- Decision Date
- March 7, 2001
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
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 SURGICAL LASER TECHNOLOGIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K042211 | MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS | Nov 8, 2004 | Substantially Equivalent |
| K023624 | SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 | Jan 27, 2003 | Substantially Equivalent |
| K011409 | SLT LASERPRO CTH HOLMIUM LASER SYSTEM | Jun 14, 2001 | Substantially Equivalent |
| K984018 | HEMOSLEEVE, MODEL 4.0MM, 5.5MM | Mar 15, 1999 | Substantially Equivalent |
| K983050 | PNEUMATIC CUTTER SYSTEM | Nov 25, 1998 | Substantially Equivalent |
| K981041 | SLT BIPOLAR SHEATH | Aug 27, 1998 | Substantially Equivalent |
| K972548 | SLT CL MD CONTACT LASER SYSTEM | Apr 21, 1998 | Substantially Equivalent |
| K980156 | SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS | Feb 27, 1998 | Substantially Equivalent |
| K960821 | SLT FUMICH PROBE GUIDE | May 16, 1996 | Substantially Equivalent |
| K954727 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION) | Feb 5, 1996 | Substantially Equivalent |