DeviceClearance

EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS— 510(k) K041957

Substantially Equivalent

Diomed, Inc.

FDA 510(k) clearance K041957 for EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS, Substantially Equivalent on 2004-12-01. Applicant: Diomed, Inc.. Device class: 2.

Clearance details

Applicant
Diomed, Inc.
Product code
Code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Reading, MA, US
Download summary PDFView on FDA.gov ↗

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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, 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 →

Recalls naming K041957

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041957.

Data sourced from openFDA. This site is unofficial and independent of the FDA.