INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE— 510(k) K053540

Name: FDA 510(k) clearance K053540
Creator: U.S. Food and Drug Administration
Published: 2006-09-06

Substantially Equivalent

Intermedic Arfran, SA

FDA 510(k) clearance K053540 for INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE, Substantially Equivalent on 2006-09-06. Applicant: Intermedic Arfran, SA. Device class: 2.

Clearance details

Applicant: Intermedic Arfran, SA
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2005-12-20
Decision date: 2006-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Meza, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEX

view all

K241973 — SmartIPL_NI System2026-09-19
K252723 — Dynamis Pro Family2026-09-19
K261047 — Dental Diode Laser Device (Laser-Pen)2026-09-18
K261673 — LED Therapy Device (QLXY-01)2026-09-17
K261817 — Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)2026-09-17

More clearances from Intermedic Arfran, SA

view all

K091323 — MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)2009-06-04

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.