DeviceClearance

faceLITE— 510(k) K191629

Substantially Equivalent

Ismart Marketing Svcs, Ltd.

FDA 510(k) clearance K191629 for faceLITE, Substantially Equivalent on 2019-09-12. Applicant: Ismart Marketing Svcs, Ltd.. Device class: 2.

Clearance details

Applicant
Ismart Marketing Svcs, Ltd.
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
Birmingham, GB
Download summary PDFView on FDA.gov ↗

Recent devices under product code OHS

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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.