(11 days)
K#003614
K#003614
No
The summary describes a laser system with user-selectable parameters and does not mention any AI or ML components, image processing, or data-driven features.
Yes
The device is used for the treatment of various medical conditions such as vascular lesions, pseudofolliculitis barbae, and benign pigmented lesions. While it also removes unwanted hair, the primary use cases described indicate a therapeutic purpose.
No
The document describes the device as a laser system for treatment procedures (vascular lesions, hair removal, pigmented lesions, leg veins), not for diagnosing conditions.
No
The device description clearly outlines hardware components including a system console, handle hose, and handpiece, which deliver pulsed laser light. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a laser system for treatment of various conditions (vascular lesions, pseudofolliculitis barbae, unwanted hair, pigmented lesions, leg veins). IVDs are used for diagnosis of diseases or conditions by examining samples from the human body (like blood, urine, tissue).
- Device Description: The description details a laser system that delivers light to the body for therapeutic purposes. This is consistent with a treatment device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Milesman Premium Pulsed Diode Array Laser System is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Milesman Premium Pulsed Diode Array Laser System is intended for use in general and plastic surgery and dermatology procedures for the treatment of vascular lesions, such as angiomas, hemanqiomas, telangjectasia and other benign vascular lesions and treatment for pseudofolliculitis barbae.
The Milesman Premium is also used for removal of unwanted hair, permanent hair reduction and the treatment of benign pigmented lesions and leg veins in all skin types (Fitzpatrick I-VI), including tanned skin.
Product codes
GEX
Device Description
The Milseman Premium Pulsed Diode Array Laser System delivers pulsed laser light at 800 nm wavelength. The device consists of three interconnected sections: the system console, the handle hose (umbilical cord) to the handpiece, and the handpiece. The laser pulsed energy is delivered through the handpiece. A user is able to select specific laser parameters from the touch screen on top of the console.
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)
The Milseman Premium Pulsed Diode Array Laser System and the predicate LightSheer™ Pulsed Diode Array Laser System have very similar specifications and indications for use and as such, the performance data are not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#003614, LightSheer™ Pulsed Diode Array Laser System
Reference Device(s)
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
510(K) SUMMARY of SAFETY and EFFECTIVENESS
6073300
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is:
1. Submitter's Identification:
Milesman, S.L. Max Planck 545, P.I. Roces, 33211 Gijon, Asturias, Spain
DEC 0 4 2007
Date Summary Prepared: August 15, 2007
2. Name of the Device:
| Trade Name: | Milesman Premium Pulsed Diode Array Laser System |
|---|---|
| Classification Name: | Laser Instrument, Surgical, Powered |
| 21CFR Part 878.4810 | |
| Product Code: GEX | |
| Review Panel: General & Plastic Surgery |
3. Predicate Device Information:
K#003614, LightSheer™ Pulsed Diode Array Laser System
4. Device Description:
The Milseman Premium Pulsed Diode Array Laser System delivers pulsed laser light at 800 nm wavelength. The device consists of three interconnected sections: the system console, the handle hose (umbilical cord) to the handpiece, and the handpiece. The laser pulsed energy is delivered through the handpiece. A user is able to select specific laser parameters from the touch screen on top of the console.
1
5. Intended Use:
The Milesman Premium Pulsed Diode Array Laser System is intended for use in general and plastic surgery and dermatology procedures for the treatment of vascular lesions, such as angiomas, hemanqiomas, telangjectasia and other benign vascular lesions and treatment for pseudofolliculitis barbae.
The Milesman Premium is also used for removal of unwanted hair, permanent hair reduction and the treatment of benign pigmented lesions and leg veins in all skin types (Fitzpatrick I-VI), including tanned skin.
6. Comparison to Predicate Device:
The Milesman Premium and the LightSheer ET are very similar or identical in terms of the device structure and its technology. Both systems are medical laser devices that deliver intense pulsed light at 800nm and are designed for effective photothermolysis treatment of soft tissue in general and plastic surgery, i.e. benign pigmented lesions, vascular lesions, leg veins, and removal of unwanted hair and permanent hair reduction.
The main differences between the Milesman Premium and LightSheer™ devices are in the refrigeration systems and in the number of diode lasers. The Milesman Premium and predicate LightSheer™ ET use different methods for obtaining the refrigeration with Milesman Premium refrigeration based on refrigeration by compression which is more efficient than thermoelectric refrigeration used by the predicate device. The diode laser array of Milesman Premium is formed by 2 matrixes of 10 the bars. The LightSheer™ ET diode array is formed by 2 matrixes of 35 bars. Due to a different method of bars assembly, the Milesman Premium is able to deliver the same amount of energy as LightSheer™ while using fewer diode lasers.
The above features of Milesman Premium do not introduce any new questions regarding the safety and effectiveness of the device.
7. Performance Data:
The Milseman Premium Pulsed Diode Array Laser System and the predicate LightSheer™ Pulsed Diode Array Laser System have very similar specifications and indications for use and as such, the performance data are not required.
8. Discussion of Clinical Tests Performed:
Non-Applicable
2
9. Conclusion:
The Milseman Premium Pulsed Diode Array Laser System has the same intended use and similar characteristics as the LightSheer™ Pulsed Diode Array Laser System. Moreover, documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Milesman Premium System is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2007
Milesman, S.L. % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K073300
Trade/Device Name: Milesman Premium Pulsed Diode Array 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: II Product Code: GEX Dated: November 21, 2007 Received: November 23, 2007
Dear Mr. Lehtonen:
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.
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 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - Mr. Daniel W. Lehtonen
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
Page _ 1______________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _ k_() 7 3 3 0 0
| Device Name | Milesman Premium Pulsed Diode Array Laser System |
|---|---|
| ------------- | -------------------------------------------------- |
The Milesman Premium Pulsed Diode Array Laser System is intended for use in general and plastic surgery and dermatology procedures for the treatment of vascular lesions, such as angiomas, hemangiomas, telangiectasia and other benign vascular lesions and treatment for pseudofolliculitis barbae.
The Milesman Premium is also used for removal of unwanted hair, permanent hair reduction and the treatment of benign pigmented lesions and leg veins in all skin types (Fitzpatrick I-VI), including tanned skin.
Prescription Use X Over-The Counter Use OR (Per 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
일부노동========================================================================================================================================================================= Concurrence of CDRH, Office of Device Evaluation ODE)
Evaluation (SDE)
(Division Sigand Neurological Devices
510(k) Number k, 073300