OptiLUV Device
K-Number: K250734 · 2025-09-10
ApplicantPollogen, Ltd.
Decision Date2025-09-10
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
OptiLUV Device is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2025-09-10 under approval number K250734. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OptiLUV Device?
OptiLUV Device is a medical device that received FDA 510(k) clearance on 2025-09-10. It is manufactured by Pollogen, Ltd.. The 510(k) number is K250734.
When was OptiLUV Device approved by the FDA?
OptiLUV Device received FDA 510(k) clearance on 2025-09-10, under approval number K250734.
What company makes OptiLUV Device?
OptiLUV Device is manufactured by Pollogen, Ltd..
What is the FDA product code for OptiLUV Device?
The FDA product code for OptiLUV Device is PBX.
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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.