SURGICAL LASER MICRO-TIPS— 510(k) K844644
Substantially EquivalentSurgical Laser Technologies, Inc.
FDA 510(k) clearance K844644 for SURGICAL LASER MICRO-TIPS, Substantially Equivalent on 1985-05-10. 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
- Villa Hills, KY, 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.