DeviceClearance

5 Wavelength LED Facemask (TN2508)— 510(k) K260598

Substantially Equivalent

iSMART Developments, Ltd.

FDA 510(k) clearance K260598 for 5 Wavelength LED Facemask (TN2508), Substantially Equivalent on 2026-07-24. Applicant: iSMART Developments, Ltd.. Device class: 2.

Summary

iSMART Developments' 5 Wavelength LED Facemask (TN2508) is filed under OHS, light-based over-the-counter wrinkle reduction. The name gives five wavelengths, but the record doesn't list them.

Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).

iSMART Developments filed from Birmingham, United Kingdom. The decision came 150 calendar days after receipt (February 24 to July 24, 2026).

Clearance details

Applicant
iSMART Developments, Ltd.
Product code
Product 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 ↗

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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.