IPL400
K-Number: K250384 · 2025-05-23
ApplicantEl Global Trade, Ltd.
Decision Date2025-05-23
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
IPL400 is a medical device manufactured by El Global Trade, Ltd.. It received FDA 510(k) clearance on 2025-05-23 under approval 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. It is manufactured by El Global Trade, Ltd.. The 510(k) number is K250384.
When was IPL400 approved by the FDA?
IPL400 received FDA 510(k) clearance on 2025-05-23, under approval number K250384.
What company makes IPL400?
IPL400 is manufactured by El Global Trade, Ltd..
What is the FDA product code for IPL400?
The FDA product code for IPL400 is OHT.
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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.