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Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230228
510(k) Type
Special
Applicant
Iridex Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/23/2023
Days to Decision
27 days
Submission Type
Summary

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230228
510(k) Type
Special
Applicant
Iridex Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/23/2023
Days to Decision
27 days
Submission Type
Summary