FDA 510(k)

handLITE (TN19S)

K-Number: K250224 · 2025-04-18

Decision Date2025-04-18

Product CodeONE

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

handLITE (TN19S) is the device name listed in this FDA 510(k) record. The listed applicant is iSMART Developments, Ltd.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) 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. The listed applicant is iSMART Developments, Ltd.. The 510(k) number is K250224.

When did handLITE (TN19S) receive FDA 510(k) clearance?

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

Who is the listed applicant for handLITE (TN19S)?

The FDA 510(k) record lists iSMART Developments, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing iSMART Developments, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2605985 Wavelength LED Facemask (TN2508)K242382décoLITE LED Device K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))

Related Devices (Code: ONE)

K171055Philips BlueControlPhilips Electronics Nederland B.V.

Official Source

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