(87 days)
Not Found
No
The provided text describes a laser system with various hand unit inserts for different treatments and integrated cooling. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or intended use.
Yes.
The device is used for coagulation and hemostasis of various vascular lesions, treatment of wrinkles, and hair removal, all of which are therapeutic applications.
No
The MYDON C device is described for treating benign vascular lesions, wrinkles, and for hair removal. Its function is therapeutic (treatment/removal), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly outlines a physical laser system with a handpiece, fiber optics, and an integrated cooling system, indicating it is a hardware device with potentially embedded software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The MYDON C laser system is a therapeutic device that directly interacts with the patient's skin using laser energy. It is used for treatments like coagulation, hair removal, and wrinkle reduction. These are all procedures performed on the body ("in vivo").
- Intended Use: The stated intended uses are all related to treating conditions on the skin, not analyzing samples taken from the body.
- Device Description: The description details a laser system with a handpiece that applies energy and cooling to the skin. There is no mention of analyzing biological samples.
Therefore, the MYDON C laser system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
- 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 3. 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data None presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K023954, K020021, K022839, K032220
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
2
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
Am Wolfsmantel 5
91058 Erlangen
Germany |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-207-1246 |
| Summary Preparation Date: | April 28, 2004 |
| Names | |
| Device Name: | MYDON C |
| Classification Name: | Laser Instrument, Surgical Powered
Product Code: GEX
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
1
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:
-
- 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 3. 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.
-
- Performance Data None presented.
2
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.
3
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
4
510(k) Number (if known) K 040 384
Device Name MYDON C
Indications for Use:
-
- 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 3. 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.
(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) |
OR
| 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 |
|---|---|
| --------------- | --------- |