MYDON C

K040384 · Wavelight Laser Technologie AG · GEX · May 14, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040384
• Device Name: MYDON C
• Applicant: Wavelight Laser Technologie AG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. 2. The MYDON C laser system is also indicated for the treatment of wrinkles. The MYDON C is also indicated for the removal of unwanted hair and for the 3. treatment of pseudofolliculitis barbae (PFB). 4. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. 5. The intended use of the integral cooling system in the MYDON C laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Device Story

MYDON C is 1064 nm solid-state long-pulsed Nd:YAG laser system; delivers laser energy via quartz fiber transmission system to hand unit. Integrated skin cooling system in hand unit cools treatment area before, during, and after laser pulse. Hand unit inserts (1.5 mm to 10 mm) allow varied treatment types; 1.5/3 mm for vascular lesions; 5 mm for vascular lesions/wrinkles; 7/10 mm for hair removal. Used by clinicians in dermatology/plastic surgery settings. Cooling system enables higher fluences, reduces pain, and minimizes side effects. Device output is laser energy for coagulation, hemostasis, and thermal tissue effects.

Clinical Evidence

No clinical data presented.

Technological Characteristics

1064 nm solid-state long-pulsed Nd:YAG laser; quartz fiber transmission; integrated skin cooling system in hand unit; interchangeable hand unit inserts (1.5 mm to 10 mm); electrical energy source.

Indications for Use

Indicated for patients requiring coagulation/hemostasis of benign vascular lesions (e.g., port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg/spider veins), wrinkle treatment, hair removal, and treatment of pseudofolliculitis barbae. Suitable for all Fitzpatrick skin types I-VI, including tanned skin.

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.

Predicate Devices

• Altus Medical CoolGlide Aesthetics Laser (K023954)
• Laserscope Lyra Surgical Laser System (K020021)
• Fotona DUALIS XP Plus Nd: YAG Laser System (K022839)
• Adept Medical Concepts 1064/532 Laser (K032220)

Submission Summary (Full Text)

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K 040384

# 510(k) Summary of Safety and Effectiveness for the WaveLight Laser Technologie, AG MYDON C

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### 1. General Information

| Submitter: | WaveLight Laser Technologie, AG<br>Am Wolfsmantel 5<br>91058 Erlangen<br>Germany |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | April 28, 2004 |
| Names | |
| Device Name: | MYDON C |
| Classification Name: | Laser Instrument, Surgical Powered<br>Product Code: GEX<br>Panel: Dermatology and Plastic Surgery |

#### 3. Predicate Devices

The MYDON C laser system is substantially equivalent to the Altus Medical CoolGlide Aesthetics Laser (K023954), the Laserscope Lyra Surgical Laser System (K020021), the Fotona DUALIS XP Plus Nd: YAG Laser System (K022839) and the Adept Medical Concepts 1064/532 Laser (K032220).

#### 4. Device Description

The MYDON C is a 1064 nm solid-state long-pulsed Nd: YAG laser system. The beam is directed to the treatment area by a transmission system which is connected to the laser device and consists of a multifunction hose system and a tightly connected hand unit. In the multifunction hose system both laser radiation carrying quartz fiber as well as the cooling and signal leads are contained. The MYDON C transmission system includes skin cooling integrated into the hand unit and cools the area of skin that the laser covers. When the applicator is placed against the skin, its

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shape and the integrated hand unit cooling system cool the treatment area before, during and after the application of the laser pulse, all in a single step.

The hand unit inserts allow for various treatment types and parameter ranges. MYDON C offers the 1.5 and 3 mm hand unit inserts specifically for the treatment of vascular lesions, the 5 mm hand unit insert for the treatment of both vascular lesions and wrinkles, the 7 mm and 10 mm hand unit inserts for hair removal.

## 5. Indications for Use

The MYDON C laser system is indicated:

- 1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
- 2. The MYDON C laser system is also indicated for the treatment of wrinkles.
- The MYDON C is also indicated for the removal of unwanted hair and for the 3. treatment of pseudofolliculitis barbae (PFB).
- 4. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
- 5. The intended use of the integral cooling system in the MYDON C laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
- 6. Performance Data None presented.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing human services, knowledge, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAY 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WaveLight Laser Technologie AG c/o Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864

Re: K040384 Trade/Device Name: MYDON C 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: February 13, 2004 Received: February 17, 2004

Dear Ms. O'Connell:

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 interstatc 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 Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, I-DA 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 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.

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Page 2 - Ms. Maureen O'Connell

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known) K 040 384

Device Name MYDON C

### Indications for Use:

- 1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
- 2. The MYDON C laser system is also indicated for the treatment of wrinkles.
- The MYDON C is also indicated for the removal of unwanted hair and for the 3. treatment of pseudofolliculitis barbae (PFB).
- 4. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
- 5. The intended use of the integral cooling system in the MYDON C laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number_

| Prescription Use | <div style="display:inline-block;"> <div style="border-bottom: 1px solid black; width: 20px;"></div> </div> |
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| (Per 21 CFR 801.109) | |

OR

| Over The Counter Use | <div style="display:inline-block;"> <div style="border-bottom: 1px solid black; width: 20px;"></div> </div> |
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| | Miriam C. Provost (Optional Format 1-2-96) |
|--|--------------------------------------------|
| | (Division Sign-Off) |

Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K040384 |
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