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Laser Helmet LH40-EVO

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161046
510(k) Type
Special
Applicant
Theradome, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/12/2016
Days to Decision
29 days
Submission Type
Summary

Laser Helmet LH40-EVO

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161046
510(k) Type
Special
Applicant
Theradome, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/12/2016
Days to Decision
29 days
Submission Type
Summary