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510(k) K221574

Device
LUDWIG Electrosurgical Device
Applicant
Aesthetics Biomedical
510(k) number
K221574
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-16
Date received
2022-06-01
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lawrence A. Rheins
Address
4602 N. 16th St., Suite 300 Phoenix AZ US 85016 85016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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