Last synced on 4 February 2023 at 10:33 pm

R:GEN Laser System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153769
510(k) Type
Traditional
Applicant
Lutronic Corporation
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/5/2016
Days to Decision
280 days
Submission Type
Summary

R:GEN Laser System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153769
510(k) Type
Traditional
Applicant
Lutronic Corporation
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/5/2016
Days to Decision
280 days
Submission Type
Summary