SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS— 510(k) K980156
Substantially EquivalentSurgical Laser Technologies, Inc.
FDA 510(k) clearance K980156 for SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS, Substantially Equivalent on 1998-02-27. Applicant: Surgical Laser Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Laser Technologies, Inc.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montgomeryville, PA, US
Recent devices under product code GEX
view allMore clearances from Surgical Laser Technologies, Inc.
view all- K042211 — MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
- K023624 — SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
- K011409 — SLT LASERPRO CTH HOLMIUM LASER SYSTEM
- K010041 — SLT DIFFUSER FIBER
- K984018 — HEMOSLEEVE, MODEL 4.0MM, 5.5MM
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.