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FDA 510(k)

LED Light Therapy Masks (PE748, PE749, PE756)

K-Number: K261496 · 2026-08-04

ApplicantDuplex International Trading Limited
Decision Date2026-08-04
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Masks (PE748, PE749, PE756) is the device name listed in this FDA 510(k) record. The listed applicant is Duplex International Trading Limited. It received FDA 510(k) clearance on 2026-08-04 under 510(k) number K261496. 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 LED Light Therapy Masks (PE748, PE749, PE756)?

LED Light Therapy Masks (PE748, PE749, PE756) is a medical device that received FDA 510(k) clearance on 2026-08-04. The listed applicant is Duplex International Trading Limited. The 510(k) number is K261496.

When did LED Light Therapy Masks (PE748, PE749, PE756) receive FDA 510(k) clearance?

LED Light Therapy Masks (PE748, PE749, PE756) received FDA 510(k) clearance on 2026-08-04, under 510(k) number K261496.

Who is the listed applicant for LED Light Therapy Masks (PE748, PE749, PE756)?

The FDA 510(k) record lists Duplex International Trading Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Masks (PE748, PE749, PE756)?

The FDA product code for LED Light Therapy Masks (PE748, PE749, PE756) is OHS.

Other records listing Duplex International Trading Limited 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.

K214101Project E Beauty LED Light Therapy Mask (Model: PE730)

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.

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.K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.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.

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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