Last synced on 12 October 2025 at 8:21 pm

XERF

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K251327
510(k) Type
Traditional
Applicant
Lutronic Corporation
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/11/2025
Days to Decision
103 days
Submission Type
Summary

XERF

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K251327
510(k) Type
Traditional
Applicant
Lutronic Corporation
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/11/2025
Days to Decision
103 days
Submission Type
Summary