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FDA 510(k)

LED Therapy Light (COB1400, HP1800PRO)

K-Number: K253874 · 2026-03-03

ApplicantShenzhen Hanhua Opto Co., Ltd.
Decision Date2026-03-03
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Therapy Light (COB1400, HP1800PRO) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hanhua Opto Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K253874. 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 Therapy Light (COB1400, HP1800PRO)?

LED Therapy Light (COB1400, HP1800PRO) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Shenzhen Hanhua Opto Co., Ltd.. The 510(k) number is K253874.

When did LED Therapy Light (COB1400, HP1800PRO) receive FDA 510(k) clearance?

LED Therapy Light (COB1400, HP1800PRO) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K253874.

Who is the listed applicant for LED Therapy Light (COB1400, HP1800PRO)?

The FDA 510(k) record lists Shenzhen Hanhua Opto Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Therapy Light (COB1400, HP1800PRO)?

The FDA product code for LED Therapy Light (COB1400, HP1800PRO) is OHS.

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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