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FDA 510(k)

handLITE (TN19S)

K-Number: K250224 · 2025-04-18

ApplicantiSMART Developments, Ltd.
Decision Date2025-04-18
Product CodeONE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

handLITE (TN19S) is a medical device manufactured by iSMART Developments, Ltd.. It received FDA 510(k) clearance on 2025-04-18 under approval number K250224. The device is classified under product code ONE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the handLITE (TN19S)?

handLITE (TN19S) is a medical device that received FDA 510(k) clearance on 2025-04-18. It is manufactured by iSMART Developments, Ltd.. The 510(k) number is K250224.

When was handLITE (TN19S) approved by the FDA?

handLITE (TN19S) received FDA 510(k) clearance on 2025-04-18, under approval number K250224.

What company makes handLITE (TN19S)?

handLITE (TN19S) is manufactured by iSMART Developments, Ltd..

What is the FDA product code for handLITE (TN19S)?

The FDA product code for handLITE (TN19S) is ONE.

Other Devices by iSMART Developments, Ltd.

K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) K242382décoLITE LED Device

Related Devices (Code: ONE)

K171055Philips BlueControlPhilips Electronics Nederland B.V.

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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