Source document or public record
FDA 510(k) K242388 — LensHooke X12 PRO Semen Analysis System
FDA 510(k) index record K242388. Device: LensHooke X12 PRO Semen Analysis System. Applicant as listed: Bonraybio Co., Ltd.. Decision date: 2025-05-09.
Source
"device_name": "LensHooke X12 PRO Semen Analysis System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K242388.
Device name: LensHooke X12 PRO Semen Analysis System. Applicant as listed: Bonraybio Co., Ltd..
Decision date: 2025-05-09. Decision wording: Substantially Equivalent.
Product code: POV. Regulation: 21 CFR 864.5220. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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