3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200— 510(k) K142722

Substantially Equivalent

Livetec GmbH

FDA 510(k) clearance K142722 for 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200, Substantially Equivalent on 2015-01-13. Applicant: Livetec GmbH. Device class: 2.

Clearance details

Applicant
Livetec GmbH
Product code
Code ILY
Device class
Class 2
Regulation
21 CFR 890.5500
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Loerrach, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ILY

product code ILY
Death
3
Total
3

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.