DeviceClearance

LED Eye Perfector, model: EY-36A, EY-36B— 510(k) K221444

Substantially Equivalent

Light Tree Ventures Europe B.V.

FDA 510(k) clearance K221444 for LED Eye Perfector, model: EY-36A, EY-36B, Substantially Equivalent on 2022-12-08. Applicant: Light Tree Ventures Europe B.V.. Device class: 2.

Clearance details

Applicant
Light Tree Ventures Europe B.V.
Product code
Code OHS
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
Den Haag, NL
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OHS

product code OHS
Other
1
Total
1

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.