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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 the device name listed in this FDA 510(k) record. The listed applicant is iSMART Developments, Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) 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. The listed applicant is iSMART Developments, Ltd.. The 510(k) number is K242382.

When did décoLITE LED Device receive FDA 510(k) clearance?

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

Who is the listed applicant for décoLITE LED Device?

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 décoLITE LED Device?

The FDA product code for décoLITE LED Device is OHS.

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

Related Devices (Code: OHS)

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.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

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.

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