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Renuvion/J-Plasma Precise Handpiece

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191484
510(k) Type
Traditional
Applicant
Apyx Medical Corporation(formerly Bovie Medical Corporation)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/30/2019
Days to Decision
56 days
Submission Type
Summary

Renuvion/J-Plasma Precise Handpiece

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191484
510(k) Type
Traditional
Applicant
Apyx Medical Corporation(formerly Bovie Medical Corporation)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/30/2019
Days to Decision
56 days
Submission Type
Summary