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FDA 510(k)

LensHooke X12 PRO Semen Analysis System

K-Number: K242388 · 2025-05-09

ApplicantBonraybio Co., Ltd.
Decision Date2025-05-09
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LensHooke X12 PRO Semen Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Bonraybio Co., Ltd.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K242388. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LensHooke X12 PRO Semen Analysis System?

LensHooke X12 PRO Semen Analysis System is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Bonraybio Co., Ltd.. The 510(k) number is K242388.

When did LensHooke X12 PRO Semen Analysis System receive FDA 510(k) clearance?

LensHooke X12 PRO Semen Analysis System received FDA 510(k) clearance on 2025-05-09, under 510(k) number K242388.

Who is the listed applicant for LensHooke X12 PRO Semen Analysis System?

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

What is the FDA product code for LensHooke X12 PRO Semen Analysis System?

The FDA product code for LensHooke X12 PRO Semen Analysis System is POV.

Related Clinical Trials

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NCT07621991Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ARTNOT_YET_RECRUITING

Other records listing Bonraybio Co., 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.

K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerK221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceK202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerK180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer

Related Devices (Code: POV)

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.

K252228Seaman Pro/SeamanCheckcells, Inc.K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.K243114SQA-iOw Sperm Quality AnalyzerMedical Electronic Systems , Ltd.K241628YO Home Sperm TestMedical Electronic Systems , Ltd.K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , Ltd.K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.

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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