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Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221712
510(k) Type
Traditional
Applicant
Fotona d.o.o.
Country
Slovenia
FDA Decision
Substantially Equivalent
Decision Date
10/12/2022
Days to Decision
121 days
Submission Type
Summary

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221712
510(k) Type
Traditional
Applicant
Fotona d.o.o.
Country
Slovenia
FDA Decision
Substantially Equivalent
Decision Date
10/12/2022
Days to Decision
121 days
Submission Type
Summary