Decision Date2025-12-23
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Philips Lumea IPL is the device name listed in this FDA 510(k) record. The listed applicant is Philips Consumer Lifestyle B.V.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253754. 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 Philips Lumea IPL?
Philips Lumea IPL is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Philips Consumer Lifestyle B.V.. The 510(k) number is K253754.
When did Philips Lumea IPL receive FDA 510(k) clearance?
Philips Lumea IPL received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253754.
Who is the listed applicant for Philips Lumea IPL?
The FDA 510(k) record lists Philips Consumer Lifestyle B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Philips Lumea IPL?
The FDA product code for Philips Lumea IPL is OHT.
Other records listing Philips Consumer Lifestyle B.V. 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.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.