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FDA 510(k)

décoLITE LED Device

K-Number: K242382 · 2024-11-08

ApplicantiSMART Developments, Ltd.
Decision Date2024-11-08
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

décoLITE LED Device is a medical device manufactured by iSMART Developments, Ltd.. It received FDA 510(k) clearance on 2024-11-08 under approval number K242382. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the décoLITE LED Device?

décoLITE LED Device is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by iSMART Developments, Ltd.. The 510(k) number is K242382.

When was décoLITE LED Device approved by the FDA?

décoLITE LED Device received FDA 510(k) clearance on 2024-11-08, under approval number K242382.

What company makes décoLITE LED Device?

décoLITE LED Device is manufactured by iSMART Developments, Ltd..

What is the FDA product code for décoLITE LED Device?

The FDA product code for décoLITE LED Device is OHS.

Other Devices by iSMART Developments, Ltd.

K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) K250224handLITE (TN19S)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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