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510(k) Data Aggregation
K Number
K221873Device Name
NeoGen PSR System
Manufacturer
Date Cleared
2023-01-12
(198 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Energist Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
When used with the 5mm nozzle the NeoGen PSR System is intended for treatment of the following dermatological conditions :
- · Treatment of wrinkles and rhytids
- · Superficial skin lesions
- · Actinic Keratosis
- Viral Papillomata
- · Seborrheic Keratosis
- · Acne Scars
When used with the 25mm nozzle, the NeoGen PSR System is intended for coagulation of tissue in dermatological procedures.
Device Description
The system comprises the following major elements:
- . The Energist NeoGen PSR generator. This incorporates a source of Ultra High Frequency (UHF) energy and the gas control system required to support creation of nitrogen plasma;
- . A Footswitch – single pedal type for activation of the plasma output.
- . A handpiece that connects to the generator via an umbilical, which incorporates electrical and gas connections. The handpiece incorporates a finger-operated button switch that can be used to activate the plasma as an alternative to the footswitch.
- . A Procedure Pack, comprising one or more limited life disposable tips (nozzles) through which the plasma is delivered. These are a snap fit to the distal end of the handpiece;
- A gas supply system - principally a nitrogen gas cylinder and a regulator assembly;
- . A bespoke trolley which provides a secure, mobile platform for the generator, handpiece, gas cylinder (plus a spare cylinder) and gas regulator assembly.
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