Last synced on 30 September 2022 at 11:05 pm

Iridex 810 Laser

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213592
510(k) Type
Special
Applicant
Iridex Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/23/2022
Days to Decision
131 days
Submission Type
Summary

Iridex 810 Laser

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213592
510(k) Type
Special
Applicant
Iridex Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/23/2022
Days to Decision
131 days
Submission Type
Summary