The MeDioStar NeXT Family

K143519 · Asclepion Laser Technologies GmbH · GEX · Mar 10, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K143519
• Device Name: The MeDioStar NeXT Family
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 10, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MeDioStar NeXT Family laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology. The MeDioStar NeXT Family laser system is intended for the treatment of benign vascular lesions. The MeDioStar NeXT Family laser system is intended for the treatment of benign pigmented lessons. The MeDioStar NeXT Family laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.

Device Story

Pulsed diode laser system (755-950 nm) for surgical, aesthetic, and cosmetic applications. Device comprises main console, footswitch, and various contact-cooled handpieces. Operator (physician/trained professional) selects handpiece and parameters; laser energy delivered to skin to treat benign vascular/pigmented lesions or reduce hair growth. Principle of operation relies on selective photothermolysis; energy absorption by target chromophores (melanin, hemoglobin) causes thermal destruction. Output is laser light; clinical decision-making based on visual assessment of skin condition/hair growth. Benefits include non-invasive treatment of lesions and long-term hair reduction.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance data and comparison of technical specifications to predicate devices.

Technological Characteristics

Pulsed diode laser; wavelength 755-950 nm; pulse duration up to 400 ms; repetition rate 4-12 Hz; max fluence 20-210 J/cm² depending on handpiece. System includes main console, footswitch, and multiple contact-cooled handpieces. Standalone device.

Indications for Use

Indicated for surgical, aesthetic, and cosmetic applications in general/plastic surgery and dermatology; treatment of benign vascular lesions; treatment of benign pigmented lesions; and hair reduction (defined as reduced hair growth at 6, 9, and 12 months).

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

• MeDioStar NeXT (K111851)
• Alma Lasers 755 nm Diode Module (K140009)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines extending from their chins. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2015

Asclepion Laser Technologies GmbH Antje Katzer Regulatory Affairs Manager Brüsseler Straße 10 07747 Jena, Thuringia Germany

Re: K143519

Trade/Device Name: MeDioStar NeXT Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: February 5, 2015 Received: February 11, 2015

Dear Ms. Antje Katzer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143519

#### Device Name

MeDioStar NeXT Family

Indications for Use (Describe)

The MeDioStar NeXT Family laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.

The MeDioStar NeXT Family laser system is intended for the treatment of benign vascular lesions.

The MeDioStar NeXT Family laser system is intended for the treatment of benign pigmented lessons.

The MeDioStar NeXT Family laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Asclepion Laser Technologies. The word "Asclepion" is written in gray, and below it, "Laser Technologies" is written in a smaller font, also in gray. To the right of the word "Asclepion" is a cluster of blue circles of varying sizes, arranged in a pattern.

Asclepion Laser Technologies GmbH • Brüsseler Str. 10 • 07747 Jena • Germany

## Special 510(k) SUMMARY

### MeDioStar NeXT Family

This Special 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MeDioStar NeXT Family is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.

| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH<br>Bruesseler Str. 10<br>07747 Jena, Germany |
|---------------------------|---------------------------------------------------------------------------------|
| Contact Person: | Mrs. Antje Katzer<br>Product Management and<br>International Regulatory Affairs |
| Phone:<br>Fax:<br>e-mail: | [phone]<br>[phone]<br>[e-mail] |
| Preparation Date: | March 5, 2015 |
| Device Name: | MeDioStar NeXT Family |
| Common Name: | Diode Laser |

Our general terms and conditions: www.asclepion.com

Registered office: Jena Register of commerce court: Jena HRB 209648 UST ID Nr. DE 813678553 WEEE-Reg.-Nr. DE 33663120 Managing Director: Dr. Danilo Leggieri

Bank Connections: Sparkasse Jena • SWIFT HELADEF1JEN • IBAN DE 348305303000000000094 Deutsche Bank Jena • SWIFT DEUTDE8EXXX • IBAN DE 67820700000397755000 Commerzbank Jena • SWIFT COBADEFF821 • IBAN DE 54820400000258272400

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| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology<br>79-GEX<br>21 CFR 878.4810<br>Regulatory Class: Class II<br>Product Code: GEX |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalent Devices: | MeDioStar NeXT K111851 |
| | Alma Lasers 755 nm Diode Module K140009 |
| Device Description: | The MeDioStar NeXT and the MeDioStar NeXTPRO (The MeDioStar NeXT<br>Family) are pulsed diode lasers emitting a wavelength of 755 - 950 nm, that<br>are operated with a handpiece in contact with the skin. The lasers are a<br>modification to previously cleared MeDioStar NeXT K111851. All systems<br>comprise a main console unit, a handpiece and are triggered by means of a<br>footswitch. There are several handpieces, the user can chose from. |
| Intended Use: | The MeDioStar NeXT Family laser system is intended for surgical, aesthetic<br>and cosmetic applications in the medical specialties of general and plastic<br>surgery and dermatology. |
| | The MeDioStar NeXT Family laser system is intended for the treatment of<br>benign vascular lesions. |
| | The MeDioStar NeXT Family laser system is intended for the treatment of<br>benign pigmented lesions. |
| | The MeDioStar NeXT Family laser system is intended for hair removal,<br>permanent hair reduction defined as reduced hair growth with or without<br>maintenance when measured at 6, 9 and 12 months. |

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## Summary of Technical Characteristics

| | Un-Modified Predicate<br>Device | Un-Modified Predicate<br>Device | Proposed Modified Device | Proposed Modified Device |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| | MedioStar NeXT | Alma Lasers 755 nm Diode<br>Module | The MeDioStar NeXT Family | |
| | | | MeDioStar NeXTPRO | MeDioStar NeXT |
| | K111851 | K140009 | | |
| Intended Use | Intended for surgical,<br>aesthetic and cosmetic<br>applications in the medical<br>specialties of general and<br>plastic surgery and<br>dermatology.<br>Intended for the treatment of<br>vascular lesions.<br>Intended for hair removal,<br>permanent hair reduction and<br>the treatment of pigmented<br>lesions. | Permanent reduction in hair<br>regrowth.<br>Treatment of benign vascular<br>and pigmented lesions.<br>Indicated for use on all skin<br>types<br>(Fitzpatrick skin types I - VI),<br>including tanned skin.<br>Permanent reduction in hair<br>regrowth is defined as long<br>term, stable reduction in the<br>numbers of hairs re-growing<br>when measured at 6, 9 and 12<br>months after the completion<br>of a treatment regime. | Intended for surgical, aesthetic and cosmetic applications<br>in the medical specialties of general and plastic surgery<br>and dermatology.<br>Intended for the treatment of benign vascular lesions.<br>Intended for the treatment of benign pigmented lesions.<br>Intended for hair removal, permanent hair reduction<br>defined as reduced hair growth with or without<br>maintenance when measured at 6, 9 and 12 months. | |
| Device Type | Diode Laser | Diode Laser | Diode Laser | Diode Laser |
| Wavelength | 800 - 950 nm | 755 nm | 755 - 950 nm | 755-950 nm |
| Pulse Duration | Up to 400 ms | Up to 200 ms | Up to 400 ms | Up to 400 ms |
| Repetition Rate | 4 - 12 Hz | 0,5 – 10 Hz | 4 - 12 Hz | 4 – 12 Hz |
| Spot Sizes<br>(Handpieces) | 13 x 10 mm² (ST)<br>4 x 3 mm² (VAS)<br>8 x 6 mm² (HP) | 150 mm² | 13 x 10 mm² (ST)<br>4 x 3 mm² (VAS)<br>8 x 6 mm² (HP)<br>13 x 10 mm² (ALX)<br>30 x 10 mm2 (XL+XLS)<br>38 x 24 mm2 (XL+XLL) | 13 x 10 mm² (ST)<br>4 x 3 mm² (VAS)<br>8 x 6 mm² (HP)<br>13 x 10 mm² (ALX) |
| Max. Fluence<br>(Handpieces) | 44 J/cm² (ST)<br>90 J/cm² (HP)<br>210 J/cm² (VAS) | 120 J/cm² | 44 J/cm² (ST)<br>90 J/cm² (HP)<br>210 J/cm² (VAS)<br>35 J/cm² (ALX)<br>60 J/cm² (XL+XLS)<br>20 J/cm² (XL+XLL) | 44 J/cm² (ST)<br>90 J/cm² (HP)<br>210 J/cm² (VAS)<br>35 J/cm² (ALX) |

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Comparison to: The MeDioStar NeXT Family laser system is substantially equivalent to the MeDioStar NeXT K111851 with the same principles of operation, with similar parameter and the same indications for use. The fundamental scientific technology of the device is unchanged from the legally marketed predicate. The MeDioStar NeXT Family laser with handpiece ALX (755 nm) system is substantially equivalent to the Alma Lasers 755 nm Diode Module K140009 with similar parameter and the same Indications for use. Nonclinical Performance Data: None Clinical Performance Data: None Conclusion: The MeDioStar NeXT Family laser system is another safe and effective device for the treatment of benign vascular lesions, for hair removal, permanent hair reduction and the treatment of benign pigmented lesions.