décoLITE LED Device— 510(k) K242382

Name: FDA 510(k) clearance K242382
Creator: U.S. Food and Drug Administration
Published: 2024-11-08

Substantially Equivalent

iSMART Developments, Ltd.

FDA 510(k) clearance K242382 for décoLITE LED Device, Substantially Equivalent on 2024-11-08. Applicant: iSMART Developments, Ltd.. Device class: 2.

Clearance details

Applicant: iSMART Developments, Ltd.
Product code: Code OHS
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2024-08-12
Decision date: 2024-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code OHS

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K261602 — Eye Recovery Pro (PH-e03)2026-08-10
K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)2026-08-07
K261496 — LED Light Therapy Masks (PE748, PE749, PE756)2026-08-04
K261851 — LED Light Therapy Mask (5 models)2026-08-04
K261482 — LightStim for Wrinkles (1984); LightStim for Acne (2038)2026-07-31

More clearances from iSMART Developments, Ltd.

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K260598 — 5 Wavelength LED Facemask (TN2508)2026-07-24
K250224 — handLITE (TN19S)2025-04-18
K231555 — LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))2023-07-27

Adverse events under product code OHS

product code OHS

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.