(266 days)
Not Found
No
The description focuses on the electrosurgical technology and its components, with no mention of AI or ML capabilities.
Yes
The device is intended for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation, which are therapeutic indications.
No
The device is described as an electrosurgical device for treatment, specifically for skin resurfacing, soft tissue resection/removal, and hemostasis/coagulation. It is not mentioned to be used for detecting or identifying a medical condition.
No
The device description clearly outlines hardware components including an electrosurgical generator (Controller), a Handpiece and Cable Unit, and a disposable Handpiece Tip, all of which are essential for the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "general dermatologic surgery" and is used for procedures like "skin resurfacing," "soft tissue resection/removal," and "hemostasis/coagulation." These are all procedures performed on the patient's body.
- Device Description: The description details an electrosurgical system that delivers RF energy to the patient via a handpiece and tip. This is a device that directly interacts with the patient's tissue.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or analysis of biological materials.
Therefore, the Visage Cosmetic Surgery System is a therapeutic device used for surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Visage Cosmetic Surgery System is a bipolar high frequency electrosurgical device intended for general dermatologic surgery that may include skin resurfacing for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline.
Product codes
GEI
Device Description
The Visage Cosmetic Surgery System is a bipolar, high frequency electrosurgical system designed for use in general dermatologic procedures where ablation and coagulation of soft tissue is desired. The System consists of three components: an electrosurgical generator called the Controller, the disposable Handpiece Tip, and the reusable Handpiece and Cable Unit. The Controller utilizes radio frequency (RF) energy as a power source. RF energy is delivered to the patient via the Handpiece and Cable unit and the Handpiece Tip. The Handpiece and Cable unit is designed to attach to the Controller and Handpiece Tip for patient treatment. The single use, sterile, Handpiece Tip is the patient contacting component of the System. The Handpiece Tip configuration ranges from single to multiple electrodes incorporating straight, screen, loop, and sheet shaped electrodes. The Visage Cosmetic Surgery System uses bipolar technology in the design of the Handpiece Tip eliminating the need for a patient contacting dispersive pad used in monopolar devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the Visage Cosmetic Surgery System for skin resurfacing for the treatment of wrinkles, rhytids, and furrows was evaluated in accordance with an approved Investigational Device Exemption (IDE), No. G970168, "ArthroCare Dermal Electrosurgery System for Skin Resurfacing Clinical Study." The Visage Cosmetic Surgery System was found to be both safe and effective for skin resurfacing for the treatment of wrinkles, rhytids, and furrows.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K992190
510(k) Summary of Safety and Effectiveness ArthroCare, Corporation Visage™ Cosmetic Surgery System
General Information
| Manufacturer: | ArthroCare, Corporation 595 North Pastoria Avenue Sunnyvale, CA 94086-2916 |
|---|---|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Bruce Prothro, Vice President Regulatory Affairs and Quality Assurance |
| Date Prepared: | June 25, 1999 |
| Device Description | |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) |
| Trade Name: | Visage™ Cosmetic Surgery System |
| Generic/Common Name: | Electrosurgical Device and Accessories |
Predicate Devices
Visage Cosmetic Surgery System ミ K981870 ArthroCare Dermal Electrosurgery System K964849
Establishment of equivalence is based on similarities of intended use, materials, and principle of operations. Additionally, there have been no substantial changes in materials, technology or performance to the Visage Cosmetic Surgery System cleared under 510(k) K981870 and Visage Cosmetic Surgery System presented in this premarket notification.
Intended Use
The Visage Cosmetic Surgery System is a bipolar high frequency electrosurgical device intended for general dermatologic surgery that may include skin resurfacing for the
1
treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline.
Product Description
The Visage Cosmetic Surgery System is a bipolar, high frequency electrosurgical system designed for use in general dermatologic procedures where ablation and coagulation of soft tissue is desired. The System consists of three components: an electrosurgical generator called the Controller, the disposable Handpiece Tip, and the reusable Handpiece and Cable Unit. The Controller utilizes radio frequency (RF) energy as a power source. RF energy is delivered to the patient via the Handpiece and Cable unit and the Handpiece Tip. The Handpiece and Cable unit is designed to attach to the Controller and Handpiece Tip for patient treatment. The single use, sterile, Handpiece Tip is the patient contacting component of the System. The Handpiece Tip configuration ranges from single to multiple electrodes incorporating straight, screen, loop, and sheet shaped electrodes. The Visage Cosmetic Surgery System uses bipolar technology in the design of the Handpiece Tip eliminating the need for a patient contacting dispersive pad used in monopolar devices.
Substantial Equivalence
This 510(k) notification is for the expansion of the current indications to include skin resurfacing for the treatment of wrinkles, rhytids, and furrows. The Visage Cosmetic Surgery System has not been significantly modified in either technology, principles of operation, or materials since the 510(k) approval of the predicate Visage Cosmetic Surgery System on August 20, 1998 (K981870). The Visage Cosmetic Surgery System is a modification to the initial System. ArthroCare Dermal Electrosurgery System, which was cleared via K964849 on April 14, 1997.
Summary of Safety and Effectiveness
The safety and effectiveness of the Visage Cosmetic Surgery System for skin resurfacing for the treatment of wrinkles, rhytids, and furrows was evaluated in accordance with an approved Investigational Device Exemption (IDE), No. G970168, "ArthroCare Dermal Electrosurgery System for Skin Resurfacing Clinical Study." The Visage Cosmetic Surgery System was found to be both safe and effective for skin resurfacing for the treatment of wrinkles, rhytids, and furrows.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains an emblem of an eagle with three wavy lines emanating from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle. The seal is black and white.
Public Health Service
MAR 2 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bruce Prothro Vice President, Regulatory Affairs and Quality Assurance ArthroCare, Corporation 595 North Pastoria Avenue Sunnyvale, California 94086-2916
Re: K992180
Trade Name: Visage Cosmetic Surgery System Regulatory Class: II Product Code: GEI Dated: February 11, 2000 Received: February 14, 2000
Dear Mr. Prothro:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Bruce Prothro
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stig
Murds
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications Statement
Device Name: Visage Cosmetic Surgery System 510(k) Number: K992180
Indications for use:
The Visage Cosmetic Surgery System is a bipolar high frequency electrosurgical device intended for general dermatologic surgery that may include skin resurfacing for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stupt Rlwele
(Division Sign-Off) (Division of General Restorative Deyic 510(k) Number
Prescription Use X OR (Per 21 CFR 801.109)
Over-the-Counter Use