MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER— 510(k) K082707

Name: FDA 510(k) clearance K082707
Creator: U.S. Food and Drug Administration
Published: 2008-10-01

Substantially Equivalent

Medx Electronics, Inc.

FDA 510(k) clearance K082707 for MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER, Substantially Equivalent on 2008-10-01. Applicant: Medx Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Medx Electronics, Inc.
Product code: Code ILY
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2008-09-16
Decision date: 2008-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.