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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2025-09-10 under 510(k) 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. The listed applicant is Pollogen, Ltd.. The 510(k) number is K250734.

When did OptiLUV Device receive FDA 510(k) clearance?

OptiLUV Device received FDA 510(k) clearance on 2025-09-10, under 510(k) number K250734.

Who is the listed applicant for OptiLUV Device?

The FDA 510(k) record lists Pollogen, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiLUV Device?

The FDA product code for OptiLUV Device is PBX.

Other records listing Pollogen, 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: PBX)

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.

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