DeviceClearance

Shani Darden LED light therapy mask— 510(k) K214103

Substantially Equivalent

Harpar Grace International

FDA 510(k) clearance K214103 for Shani Darden LED light therapy mask, Substantially Equivalent on 2022-03-22. Applicant: Harpar Grace International. Device class: 2.

Clearance details

Applicant
Harpar Grace International
Product code
Product code OLP
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
Andover, GB
Download summary PDFView on FDA.gov ↗

Recent devices under product code OLP

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Adverse events under product code OLP

product code OLP
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.