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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 a medical device manufactured by Shenzhen Hanhua Opto Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under approval 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. It is manufactured by Shenzhen Hanhua Opto Co., Ltd.. The 510(k) number is K253874.

When was LED Therapy Light (COB1400, HP1800PRO) approved by the FDA?

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

What company makes LED Therapy Light (COB1400, HP1800PRO)?

LED Therapy Light (COB1400, HP1800PRO) is manufactured by Shenzhen Hanhua Opto Co., Ltd..

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 Clinical Trials

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Related PubMed Literature

PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

Related Devices (Code: OHS)

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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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