Aspen Laser Systems Therapy Laser System

K150138 · Aspen Laser Systems, LLC · PDZ · May 8, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150138
• Device Name: Aspen Laser Systems Therapy Laser System
• Applicant: Aspen Laser Systems, LLC
• Product Code: PDZ · General, Plastic Surgery
• Decision Date: May 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, periungual and subungual warts, neuromas, and plantar warts. The VelasII is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Device Story

VELAS II Laser System is a surgical laser device used in podiatry. It delivers laser energy to perform ablation, vaporization, excision, and coagulation of soft tissue. It is also used for the temporary increase of clear nail in patients with onychomycosis. Operated by clinicians in a clinical setting, the device provides therapeutic laser output to treat specific podiatric pathologies. The output affects clinical decision-making by providing a surgical tool for tissue management and a therapeutic modality for fungal nail infections, potentially benefiting patients by resolving soft tissue lesions and improving nail appearance.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Laser surgical instrument; energy source: laser; intended for soft tissue ablation, vaporization, excision, and coagulation; podiatric application.

Indications for Use

Indicated for patients with podiatric soft tissue conditions (warts, neuromas, matrixectomy needs) and patients with onychomycosis requiring temporary increase of clear nail.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 8, 2015

Aspen Laser Systems, LLC % Mr. A. Braun Henderson Aspen Laser Systems, LLC 970 South Dawson Way #14 Aurora, Colorado 80012

Re: K150138

Trade/Device Name: VELASII Laser System 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: PDZ, GEX Dated: January 16, 2015 Received: January 22, 2015

Dear Mr. Henderson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

## David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## Indications for Use

510(k) Number (if known) K150138

Device Name VELAS II Laser System

Indications for Use (Describe)

Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including:

* Matrixectomy, periungual and subungual warts, neuromas, and plantar warts.

The VelasII is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <b> \[X] Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> \[ ] Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|

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