(35 days)
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Not Found
No
The summary describes a laser system for hair and vascular lesion removal, with no mention of AI, ML, image processing, or data training/testing, which are typical indicators of AI/ML integration in medical devices.
No
The device is intended for cosmetic procedures (hair removal and vascular lesions), not for treating diseases or medical conditions.
No
The device is described as a laser system intended to remove unwanted body hair and vascular lesions, which are treatment functions, not diagnostic ones.
No
The device description explicitly states it consists of a laser enclosure and optic delivery system (fiber bundle and handpiece), which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove unwanted body hair and vascular lesions." This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: The description details a laser system that delivers energy to the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information about a patient's health condition.
- Any components typically associated with IVD devices (reagents, assays, sample handling systems).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This laser system does not fit that description.
N/A
Intended Use / Indications for Use
The MeDioStar XT Laser System is intended to remove unwanted body hair and vascular lesions.
Product codes
GEX
Device Description
MeDioStar XT Laser System is a pulsed diode laser with a wavelength of 808µm. It consists a laser enclosure and optic delivery system (fiber bundle and handpiece).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
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Predicate Device(s)
MeDioStar H Laser Sytsem
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
MAY 1 6 2005
Image /page/0/Picture/1 description: The image shows the logo for Asclepion Laser Technologies. The word "Asclepion" is written in a bold, sans-serif font, with a cluster of black dots of varying sizes above and to the right of the word. Below "Asclepion" is the phrase "Laser Technologies" in a smaller font.
Asclepion Laser Technologies GmbH • Göschwitzer Str. 51-52 • D-07745 Jena
510(k) SUMMARY
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ASCLEPION LASER TECHNOLOGIES GmbH MeDioStar XT Laser System
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MeDioStar XT Laser System 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
Goeschwitzer Str. 51-52
07745 Jena, Germany |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Reinhard Thieme
Quality Assurance and
International Regulatory Affairs |
| Phone: | +49 3641 220 211 |
| Fax: | +49 3641 220 322 |
| e-mail: | reinhard.thieme@asclepion.com |
| Preparation Date: | March 23, 2005 |
| Device Name: | MeDioStar XT Laser System |
| Common Name: | MeDioStar XT |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.481 |
| Equivalent Device: | MeDioStar H Laser Sytsem
(with and without skin cooling system) |
| Device Description: | MeDioStar XT Laser System is a pulsed diode laser with a
wavelength of 808µm. It consists a laser enclosure and optic
delivery system (fiber bundle and handpiece). |
000087
1
Koso 900 1/1
| Intended Use: | The MeDioStar XT Laser System is intended to remove
unwanted body hair and vascular lesions. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to: | The MeDioStar XT Laser System is substantially equivalent to
the MeDioStar H Laser System (with and without skin cooling),
with the same principles of operation, the same wavelength and
essentially the same power range as the predicate device for the
same indications for uses. |
| Nonclinical
Performance Data: | None |
| Clinical
Performance Data: | None |
| Conclusion: | The MeDioStar XT Laser System is another safe and effective
device for the removal of unwanted body hair and the treatment
of vascular lesions. |
| Additional Information: | None |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2005
Mr. Reinhard Thieme Quality Assurance and International Regulatory Affairs Asclepion Laser Technologies GmbH Goeschwitzerstrasse 51-52 Jena, Germany 07745
Re: K050900
Trade/Device Name: MeDioStar XT 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: April 26, 2005 Received: April 28, 2005
Dear Mr. Thieme:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of 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, de nees mat have been 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 or any I catala 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 Of N 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 – Mr. Reinhard Thieme
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manceing your ntial equivalence of your device to a legally premarket notification. "The PDF Intering of our 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 If you desire specific advice for your 2001 276-0115 . Also, please note the regulation entitled, Colliact the Office of Comphalled at (217) = 16 = 16 = 18 = 1 = 1 = 1 = 0 may obtain Missuranting of Icrerchee to premantonibilities under the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consults. 1/10:2018. 1/2 1/2017 1/2017 1/10/11/10 1/1
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 长6 So 960
Device Name: MeDioStar XT Laser System
Indications for Use:
The MeDioStar XT Laser System is intended to remove unwanted body hair and vascular lesions.
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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