(56 days)
Not Found
No
The summary describes a laser console with software control, but there is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is indicated for the treatment of varicose veins and varicosities, which are medical conditions, and therefore the device serves a therapeutic purpose.
No
The device is described as a laser console for the treatment of varicose veins and superficial venous incompetence, not for diagnosis. Its intended use is treatment based on procedures like superficial reflux of the Great Saphenous Vein, not for identifying or diagnosing a condition.
No
The device description explicitly states it is a "software controlled diode laser" and provides hardware specifications (output wavelength, maximum output). This indicates it is a physical device with software control, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for the treatment of varicose veins and associated conditions. IVDs are used for the diagnosis of diseases or conditions by examining specimens from the human body (like blood, urine, tissue).
- Device Description: The device is a laser console, which is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information.
Therefore, the Vari-Lase Endovenous Laser Console is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vari-Lase Endovenous Laser Console is indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Product codes
GEX
Device Description
The Vari-Lase Endovenous Laser Console is a software controlled diode laser that provides an output wavelength of 810 nm and operates at a maximum output of 15 W.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Great Saphenous Vein, lower extremity (superficial veins)
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)
Not Found
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Vascular Solutions, Inc.
K 093502
Special 510(k) Premarket Notification Vari-Lase Endovenous Laser Console
2 510(k) Summary
| Date Prepared: | December 23, 2009 | JAN - 7 2010 |
|---|---|---|
| Manufactured for: | Vascular Solutions, Inc. | |
| 6464 Sycamore Court | ||
| Minneapolis, MN 55369 | ||
| Establishment Registration #2134812 | ||
| Contact Person: | Jennifer Ruether | |
| Regulatory Affairs Associate | ||
| Tel: 763-656-4370 | ||
| Fax: 763-656-4253 | ||
| Email: jruether@vascularsolutions.com |
General Information:
| Trade Name: | Vari-Lase Endovenous Laser Console |
|---|---|
| Common Name: | Laser Console |
| Classification Name: | Laser instrument, surgical, powered |
| (21 CFR 878.4810; Product code GEX) | |
| Predicate Devices: | K062822, Vari-Lase Endovenous Laser Console |
| K051996, Diomed Delta 15 Laser Console |
Device Description:
The Vari-Lase Endovenous Laser Console is a software controlled diode laser that provides an output wavelength of 810 nm and operates at a maximum output of 15 W.
Intended Use/Indications for Use
The Vari-Lase Endovenous Laser Console is indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Substantial Equivalence
The Vari-Lase Endovenous Laser Console (15 W) substantially equivalent to the currently marketed predicate device, based on comparisons of the device classifications, technological characteristics, and the Indications for Use.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. The symbol on the right is a stylized representation of a human figure embracing an eagle, which is a common emblem associated with the HHS.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Vascular Solutions, Inc. · % Ms. Jennifer Ruether Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
JAN - 7 2010
Re: K093502
Trade/Device Name: Vari-Lase Endovenous Laser Console Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 16, 2009
Received: December 17, 2009
Dear Ms. Ruether:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
2
Page 2 - Ms. Ms. Jennifer Ruether
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Vascular Solutions, Inc.
Special 510(k) Premarket Notification Vari-Lase Endovenous Laser Console
Indications for Use
510(k) Number (if known):
Device Name: Vari-Lase® Endovenous Laser Console
Indications for Use:
The Vari-Lase procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number. K093502