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510(k) Data Aggregation
K Number
K240248Device Name
Volnewmer
Manufacturer
Classys Inc.
Date Cleared
2024-04-29
(90 days)
Product Code
GEI, ISA
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Classys Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.
Device Description
Volnewmer™ is a noninvasive monopolar radiofrequency (RF) therapy system. The radiofrequency output of the device is 6.78 MHz, and the maximum output power is 115 W.
- . Volnewmer™ delivers radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis.
- Volnewmer™ delivers energy from the disposable/reusable tip to the patient.
- . Volnewmer™ employs radiofrequency tuning to provide radiofrequency energy across a range of impedances for delivery to the patient through the disposable/reusable tip.
Volnewmer™ consists of the following components:
- Console ●
- . Handpiece x2
- Treatment Tips ●
- Accessories:
- Return Pad -
- Return Pad Cable -
- Coupling Gel -
- Footswitch -
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