(9 days)
The MeDioStar NeXT laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar NeXT laser system is intended for the treatment of vascular lesions.
The MeDioStar NeXT laser system is intended for hair removal, permanent hair reduction and the treatment of pigmented lesions.
The MeDioStar NeXT is a pulsed diode laser emitting a wavelength of 800 - 950 nm, that is operated with a handpiece in contact with the skin
This 510(k) submission for the Asclepion Laser Technologies GmbH MeDioStar NeXT does not include specific acceptance criteria or a study demonstrating that the device meets such criteria.
The submission states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
Instead, the device is deemed substantially equivalent to predicate devices (LightSheer Duet K053628 and MeDioStar XT K050900) based on similar principles of operation, parameters, and indications for use. The conclusion is that "The MeDioStar NeXT is another safe and effective device for the treatment of vascular lesions, for hair removal, permanent hair reduction and the treatment of pigmented lesions" primarily due to its similarity to already approved devices, rather than new performance data.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is explicitly stated as "None" in the provided document.
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K 111851 (1)
510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH . MeDioStar NeXT
JUL - 8 2011
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MeDioStar NeXT 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 GmbHBruesseler Str. 1007747 Jena, Germany |
|---|---|
| Contact Person: | Mrs. Antje KatzerProduct Management andInternational Regulatory Affairs |
| Phone:Fax:e-mail: | +49 3641 77 00 309+49 3641 77 00 302antje.katzer@asclepion.com |
| Preparation Date: | June 24th, 2011 |
| Device Name: | MeDioStar NeXT |
| Common Name: | MeDioStar NeXT |
| Classification Name: | Laser surgical instrument for use in general and plasticsurgery and in dermatology79-GEX21 CFR 878.4810 |
| Equivalent Devices: | LightSheer Duet K053628MeDioStar XT K050900 |
| Device Description: | The MeDioStar NeXT is a pulsed diode laser emitting awavelength of 800 - 950 nm, that is operated with ahandpiece in contact with the skin |
{1}------------------------------------------------
K IIII 851
Intended Use:
The MeDioStar NeXT laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar NeXT laser system is intended for the treatment of vascular lesions.
The MeDioStar NeXT laser system is intended for hair removal, permanent hair reduction and the treatment of pigmented lesions.
The MeDioStar NeXT is substantially equivalent to the Comparison to: LightSheer Duet Laser System K053628 with the same principles of operation, with similar parameters and the with the same indications for use. The MeDioStar NeXT is substantially equivalent to the MeDioStar XT Laser System K050900 with similar parameters and with two identical Indications for use.
Nonclinical Performance Data: None
Clinical Performance Data: None
Conclusion: The MeDioStar NeXT is another safe and effective device for the treatment of vascular lesions, for hair removal, permanent hair reduction and the treatment of pigmented lesions.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Asclepion Laser Technologies GmbH % Mrs. Antje Katzer Program Management and International Regulatory Affairs Brusseler Str. 10 Jena 07747, Germany
- 8 2011 JUL
Re: K111851
Trade/Device Name: MeDioStar NeXT 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: June 24, 2011 Received: June 29, 2011
Dear Mrs. 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.
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Page 2 - Mrs. Antje Katzer
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FIR
Mark N. Melkerson
Director
Division of Surgical, Orthopedic
And Restorative Devices
Deactiv
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number: K111851
Device Name: MeDioStar NeXT
Indications for Use:
The MeDioStar NeXT laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar NeXT laser system is intended for the treatment of vascular lesions.
The MeDioStar NeXT laser system is intended for hair removal, permanent hair reduction and the treatment of pigmented lesions.
Nil R.P. Oden for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111851
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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.