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.
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 treatment of pseudofolliculitis barbae (PFB).
The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
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 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 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.

AI/ML Overview

The provided document is a 510(k) summary for the MYDON C laser system. It describes the device, its indications for use, and a comparison to predicate devices, ultimately stating "Performance Data None presented." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria.

Here's an analysis of why each requested point cannot be addressed by the provided text:

A table of acceptance criteria and the reported device performance: Not present. The document explicitly states "Performance Data None presented."
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present. No performance data or studies are presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not present. No ground truth establishment is detailed as there's no performance study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No test set or adjudication method is mentioned.
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 present. The device mentioned is a laser system, not an AI or imaging diagnostic tool, and no clinical studies are presented.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This question is irrelevant as it's not an algorithm, but a physical laser device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present. No ground truth is discussed.
The sample size for the training set: Not present. No training set is mentioned as no performance study is detailed.
How the ground truth for the training set was established: Not present. No training set or ground truth establishment is detailed.

In summary, the provided 510(k) document for the MYDON C laser system does not include any performance data, clinical study details, acceptance criteria, or information related to expert review or ground truth establishment. The approval is based on substantial equivalence to predicate devices, rather than new clinical performance data from the applicant.

Summary

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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, AGAm Wolfsmantel 591058 ErlangenGermany
Contact Person:	Maureen O'Connell5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-207-1246
Summary Preparation Date:	April 28, 2004
Names
Device Name:	MYDON C
Classification Name:	Laser Instrument, Surgical PoweredProduct Code: GEXPanel: 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

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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.

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.
1. 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).
1. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
1. 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.
1. 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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.
1. 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).
1. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
1. 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.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number_

Prescription Use
(Per 21 CFR 801.109)

Over The Counter Use
----------------------	-------------------------------------------------------------------------------------------------------------

	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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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.