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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Vari-Lase® 90 Watt Endovenous Laser Console. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states:

"No additional testing was completed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study or testing was conducted or reported in this document. The device's approval seems to be based on its substantial equivalence to previously cleared devices and compliance with relevant medical electrical equipment standards.

Here's a breakdown of why each requested point cannot be addressed from the given input:

A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided for this specific device. The summary only lists standards with which predicate devices (and by extension, this device through equivalence) are compliant.
Sample size used for the test set and the data provenance: No test set or associated data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set or ground truth established for this device.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser console, not an AI diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable as no training set for an algorithm is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary

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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 CourtMinneapolis, MN 55369
Contact Person:	James ChapmanRegulatory Affairs AssociatePhone 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 andDermatology
Classification Name:	Laser Surgical Instrument for use in General and Plastic Surgery andin 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

Software Validation

No changes in software were required to accommodate the revised intended use; therefore, additional software validation was not required.

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Intended Use/Indications for Use

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.

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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

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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

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K080/64

1 of

Indications for Use Statement

K080104 510(k) Number:

Device Name:

Vari-Lase® 90 Watt Endovenous Laser Console

Indications for Use:

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

Regulation Number and Section

§ 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.