(72 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the laser technology and software control without mentioning any AI/ML capabilities.
Yes
The device is used for medical treatments such as hair removal, coagulation, vaporization, ablation, incision, excision of soft tissue, and treatment of varicose veins. These are all therapeutic applications.
No
This device is a therapeutic laser used for procedures like hair removal and treatment of varicose veins, not for diagnosing conditions.
No
The device description explicitly states it is a "software controlled diode laser" and a "laser console," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the Vari-Lase® 90W laser console is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The intended use of the Vari-Lase® 90W laser console is for direct treatment of the human body. This includes hair removal, soft tissue applications (coagulation, vaporization, ablation, incision, excision), and treatment of varicose veins.
The device description and intended use clearly indicate that this is a therapeutic device used directly on the patient, not a device used to analyze samples outside of the body.
N/A
Intended Use / Indications for Use
The Vari-Lase® 90W laser console is indicated for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels) and in contact mode, for the vaporization, ablation, incision, and excision of soft tissue.
The Vari-Lase® procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in 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 90 Watt Endovenous Laser Console (Vari-Lase Console) is a software controlled diode laser that provides an output wavelength of 810mm. It may be used in conjunction with a cooling system in certain surface treatment applications.
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
No additional testing was completed. MedArt has previously confirmed compliance of these products to the following standards:
EN60601-1 Medical Electrical Equipment - Part 1: General Requirements For Safety
EN60601-1-1 Medical Electrical Equipment - Part 1: General Requirements For Safety 1: Collateral Standard: Safety Requirements For Medical Electrical Systems
EN60601-2 Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
EN60601-1-4 Medical Electrical Equipment - Part 1-4. General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
EN60601-2-22 Medical Electrical Equipment - Part 2: Particular Requirements For safety - Section 2.22: Specification for Diagnostic and Therapeutic Laser Equipment
ISO 13485:2003 Medical Devices - Quality management systems - Requirements for regulatory purposes
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
p. lot 2
MAR 2 6 2008
510(k) Summary (As required by 21 CFR 807.92(c))
510(k) Number: K080104
| Date Prepared | January 11, 2008 |
|---|---|
| Amended | March 13, 2008 |
Submitter Information
| Submitter's Name:
Address: | Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis, MN 55369 |
|-------------------------------|--------------------------------------------------------------------------|
| Contact Person: | James Chapman
Regulatory Affairs Associate
Phone 763-656-4300 x308 |
Fax 763-656-4250
Device Information
| Trade Name: | Vari-Lase® Endovenous Laser Console |
|---|---|
| Common Name: | Laser Surgical Instrument for use in General and Plastic Surgery and |
| Dermatology | |
| Classification Name: | Laser Surgical Instrument for use in General and Plastic Surgery and |
| in Dermatology | |
| Class: | II |
| Product Code: | GEX |
| Regulation: | 21 CFR 870.4810 |
Predicate Devices
The Vari-Lase 90 Watt Endovenous Laser Console (Model 7542) is substantially equivalent to the Model 430(435) Diode Laser Medart Corporation (a subsidiary of Asah Medico), described in Medart 510(k) K993815 and to the current Vascular Solutions Vari-Lase console described in K062822.
Device Description
The Vari-Lase 90 Watt Endovenous Laser Console (Vari-Lase Console) is a software controlled diode laser that provides an output wavelength of 810mm. It may be used in conjunction with a cooling system in certain surface treatment applications.
Software Validation
No changes in software were required to accommodate the revised intended use; therefore, additional software validation was not required.
1
Image /page/1/Picture/0 description: The image contains handwritten text. The text on the left reads '168104'. On the right, the text reads '2 of 2'. There is a 'p.' in between the two texts.
Intended Use/Indications for Use
The Vari-Lase® 90W laser console is indicated for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels) and in contact mode, for the vaporization, ablation, incision, and excision of soft tissue.
The Vari-Lase® procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Summary of Testing
No additional testing was completed. MedArt has previously confirmed compliance of these products to the following standards:
| Standard | Description |
|---|---|
| EN60601-1 | Medical Electrical Equipment - Part 1: General Requirements For Safety |
| EN60601-1-1 | Medical Electrical Equipment - Part 1: General Requirements For Safety 1: Collateral Standard: Safety Requirements For Medical Electrical Systems |
| EN60601-2 | Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests |
| EN60601-1-4 | Medical Electrical Equipment - Part 1-4. General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems |
| EN60601-2-22 | Medical Electrical Equipment - Part 2: Particular Requirements For safety - Section 2.22: Specification for Diagnostic and Therapeutic Laser Equipment |
| ISO 13485:2003 | Medical Devices - Quality management systems - Requirements for regulatory purposes |
Statement of Equivalence
The Vari-Lase Endovenous Laser Console and associated cooling system are substantially equivalent to the currently marketed MedArt Model 430(435) Diode Laser (K993815) and the VSI Vari-Lase Endovenous Laser K033237, and based on comparisons of the device classification, indications for use, technological characteristics, and software.
Conclusion
The Vari-Lase Endovenous Laser Console and associated cooling system are substantially equivalent to the currently marketed predicate devices based on comparisons of the device classifications, indications for use, technological characteristics, and software.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2008
Vascular Solutions, Inc. % Mr. James Chapman Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K080104
Trade/Device Name: Vari-Lase® 90 Watt 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: II Product Code: GEX Dated: March 13, 2008 Received: March 14, 2008
Dear Mr. Chapman:
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 such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. James Chapman
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K080/64
1 of
Indications for Use Statement
K080104 510(k) Number:
Device Name:
Vari-Lase® 90 Watt Endovenous Laser Console
Indications for Use:
The Vari-Lase® 90W laser console is indicated for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels) and in contact mode, for the vaporization, ablation, incision, and excision of soft tissue.
The Vari-Lase® procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in 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)
Mark A. Millen
Division Division of Gener I. Restorative, and Neurological Devices
510(k) Number K080104