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K Number
K041999
Device Name
GYRUS PLASMA SKIN RESURFACING SYSTEM
Manufacturer
GYRUS MEDICAL, INC.
Date Cleared
2005-03-02

(219 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K023111
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

  • Rhytides of the face
  • Superficial skin lesions
  • Actinic Keratosis
  • Viral papillomata
  • Seborrhoeic Keratosis

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Description

The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

  • Rhytides of the face .
  • Superficial skin lesions .
  • . Actinic Keratosis
  • . Viral papillomata
  • Seborrhoeic Keratosis .

Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.

AI/ML Overview

The provided document, K041999, is a 510(k) summary for the Gyrus Plasma Skin Resurfacing (PSR) System. However, it does not contain specific details about acceptance criteria, device performance metrics, or a detailed study summary that would typically prove a device meets acceptance criteria.

The document mainly focuses on:

  • Identifying the device and its manufacturer.
  • Stating its intended use and comparison to a predicate device.
  • Confirming its substantial equivalence by the FDA.
  • Listing the specific dermatological conditions it's intended to treat.

There are no tables of acceptance criteria nor detailed study results with sample sizes, expert qualifications, or ground truth methodologies. The statement mentions "clinical studies have been done to validate the performance of the device" and "The clinical data results presented in this 510(k) notification to the FDA show that the device is substantially equivalent," but these details are not provided within the given text.

Therefore, based solely on the provided text, I cannot fill in the requested table and answer the specific questions about acceptance criteria and study details. The input document is a summary statement for regulatory clearance, not a detailed scientific study report.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.