UROTEK LASER CATHETER— 510(k) K934389

Name: FDA 510(k) clearance K934389
Creator: U.S. Food and Drug Administration
Published: 1994-02-03

Substantially Equivalent

Energy Life Systems Corp.

FDA 510(k) clearance K934389 for UROTEK LASER CATHETER, Substantially Equivalent on 1994-02-03. Applicant: Energy Life Systems Corp.. Device class: 2.

Clearance details

Applicant: Energy Life Systems Corp.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1993-09-09
Decision date: 1994-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEX

view all

K261562 — Diode Laser Therapy System2026-09-10
K262426 — Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)2026-09-10
K261589 — 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)2026-09-02
K262269 — CO2 Laser System (MBT- CO2 Laser)2026-09-01
K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)2026-08-27

More clearances from Energy Life Systems Corp.

view all

K951933 — UROTEK RE-USABLE FIBEROPTIC CABLE1995-05-26
K945560 — UROTEK LASER CATHETER1995-01-18
K945563 — CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))1994-12-15
K943409 — SIDE-FIRING UROLOGIC REFRACTIVE FIBER1994-08-23

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, 2020-01-01 through 2026-04-23. 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.