Last synced on 21 June 2024 at 11:04 pm

SMILE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213629
510(k) Type
Traditional
Applicant
Nu Eyne Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/12/2023
Days to Decision
452 days
Submission Type
Summary

SMILE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213629
510(k) Type
Traditional
Applicant
Nu Eyne Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/12/2023
Days to Decision
452 days
Submission Type
Summary