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FDA 510(k)

5 Wavelength LED Facemask (TN2508)

K-Number: K260598 · 2026-07-24

ApplicantiSMART Developments, Ltd.
Decision Date2026-07-24
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

5 Wavelength LED Facemask (TN2508) 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 2026-07-24 under 510(k) number K260598. 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 5 Wavelength LED Facemask (TN2508)?

5 Wavelength LED Facemask (TN2508) is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is iSMART Developments, Ltd.. The 510(k) number is K260598.

When did 5 Wavelength LED Facemask (TN2508) receive FDA 510(k) clearance?

5 Wavelength LED Facemask (TN2508) received FDA 510(k) clearance on 2026-07-24, under 510(k) number K260598.

Who is the listed applicant for 5 Wavelength LED Facemask (TN2508)?

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 5 Wavelength LED Facemask (TN2508)?

The FDA product code for 5 Wavelength LED Facemask (TN2508) 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.

K250224handLITE (TN19S)K242382décoLITE LED DeviceK231555LUMA 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.

K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)Dongguan Miqiang Technology Co., Ltd.K261473ChromixTermosalud S.L.K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.

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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