ERCHONIA EVRL LASER

K050672 · Erchonia Medical, Inc. · GEX · May 2, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050672
• Device Name: ERCHONIA EVRL LASER
• Applicant: Erchonia Medical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Erchonia EVRL Laser is generally indicated: - while using the red diode, for adjunctive use in providing temporary relief of a. minor chronic neck and shoulder pain of musculoskeletal origin, and - b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

Device Story

The Erchonia EVRL Laser is a dual-diode laser device used by clinicians in a professional setting. It utilizes a red laser diode for the temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin and a blue laser diode for the treatment of moderate inflammatory Acne Vulgaris. The device operates by emitting laser energy at specific wavelengths to target the indicated conditions. The clinician selects the appropriate diode based on the patient's condition. The output is intended to provide therapeutic relief or dermatological treatment, aiding the clinician in managing musculoskeletal pain and acne symptoms.

Technological Characteristics

Dual-diode laser system featuring red and blue laser diodes. Device is classified under 21 CFR 878.4810 as a laser surgical instrument for use in general and plastic surgery and dermatology. Product code: GEX.

Indications for Use

Indicated for patients with minor chronic neck and shoulder pain of musculoskeletal origin (red diode) and patients with moderate inflammatory Acne Vulgaris (blue diode).

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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MAY - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Erchonia Medical, Inc. C/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127

Re: K050672

Trade/Device Name: Erchonia EVRL Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: April 13, 2005 Received: April 14, 2005

Dear Mr. Walls:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, are cance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Costicule Hot (110-) that to novice, subject to the general controls provisions of the Act. The 1 ou may, mercrore, mailies of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (discuss controls. Existing major regulations affecting your device it may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oououncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualite or woulder with other requirements of the Act that I DA has made a dolorimistered by other Federal agencies. You must or any rederal statutes and regulations and inding, but not limited to: registration and listing (2 l comply with an the Act 31equirements) 11 CFR Part 801); good manufacturing practice requirements as set CFR Fart 807), adeling (21 CFR Part 820); and If applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Kevin Walls, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to ogin manetally your antial equivalence of your device to a legally premits in the 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 If you desire specific advice for your ac note the regulation of the regulation entitled, Colliact the Office of Compulation in (21CFR Part 807.97). You may obtain Misolanding by release to promanto no nomanto new the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

.Enclosure

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## Indications for Use

510(k) Number (if known): K050672

Device Name: Erchonia EVRL Laser

Indications for Use: The Erchonia EVRL Laser is generally indicated:

- while using the red diode, for adjunctive use in providing temporary relief of a. minor chronic neck and shoulder pain of musculoskeletal origin, and
- b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

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Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Restorative

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