SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)— 510(k) K936038
Substantially EquivalentSurgical Laser Technologies, Inc.
FDA 510(k) clearance K936038 for SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR), Substantially Equivalent on 1994-05-27. Applicant: Surgical Laser Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Laser Technologies, Inc.
- Product code
- Product code FJL
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oaks, PA, US
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More 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 FJL
product code FJL- Death
- 2
- Total
- 2
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.