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FDA 510(k)

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)

K-Number: K260946 · 2026-06-18

ApplicantGuangdong Newdermo Biotech Co., Ltd.
Decision Date2026-06-18
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K260946. 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 Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K260946.

When did LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) receive FDA 510(k) clearance?

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260946.

Who is the listed applicant for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

The FDA 510(k) record lists Guangdong Newdermo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

The FDA product code for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) is OHS.

Related Clinical Trials

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.

NCT07661004Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .NOT_YET_RECRUITING

Other records listing Guangdong Newdermo Biotech Co., 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.

K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)K260202LED Light Therapy Masks (LumiLips FAC07NA)K223544LED light therapy mask (FM-01, FM-02, FM-03)

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.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.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.

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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