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J-Plasma Precise FLEX Handpiece

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202880
510(k) Type
Traditional
Applicant
Apyx Medical Corporation (formerly Bovie Medical Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/2021
Days to Decision
98 days
Submission Type
Summary

J-Plasma Precise FLEX Handpiece

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202880
510(k) Type
Traditional
Applicant
Apyx Medical Corporation (formerly Bovie Medical Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/2021
Days to Decision
98 days
Submission Type
Summary