Decision Date2025-05-23
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
IPL400 is the device name listed in this FDA 510(k) record. The listed applicant is El Global Trade, Ltd.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K250384. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IPL400?
IPL400 is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is El Global Trade, Ltd.. The 510(k) number is K250384.
When did IPL400 receive FDA 510(k) clearance?
IPL400 received FDA 510(k) clearance on 2025-05-23, under 510(k) number K250384.
Who is the listed applicant for IPL400?
The FDA 510(k) record lists El Global Trade, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IPL400?
The FDA product code for IPL400 is OHT.
Other records listing El Global Trade, 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.
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Related Devices (Code: OHT)
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.
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Official Source
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