(89 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard laser technology components.
Yes
The device is described as being "intended for treatment of vascular and pigmented lesions," which indicates a therapeutic purpose.
No
The "Intended Use / Indications for Use" section states that "The YellowStar is intended for treatment of vascular and pigmented lesions," indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it consists of a laser enclosure, fiber optic delivery system, and a computer-controlled interface, indicating it includes hardware components beyond just software.
Based on the provided information, the YellowStar device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of vascular and pigmented lesions." This describes a therapeutic intervention performed directly on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The description mentions a "laser system," "fiber optic delivery system," and "computer controlled treatment parameter interface." These are components of a device used for delivering energy for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's condition based on sample analysis
Therefore, the YellowStar is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Laser System YellowStar intended for treatment of vascular and pigmented lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Laser System YellowStar consists of a laser enclosure, fiber optic delivery system and an computer controlled treatment parameter interface.
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
licensed professionals
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)
None. The specifications and intended uses of the laser system YellowStar are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required.
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.
K932723, K942934, K883541, K903883
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
FEB 2 6 2002
510(k) SUMMARY ASCLEPION-MEDITEC AG Laser System YellowStar
KD13940
This 510(k) summary of safety and effectiveness for the ASCLEPION-MEDITEC AG Laser System YelowStar is submitted in accordance with the requirements of SDMA 1990 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
ASCLEPION-MEDITEC AG Applicant:
- Prussingstrasse 41 Address: 07745 Jena, Germany
- Contact Person: Dr. Dirk Colditz Vice President Operations and International Regulatory Affairs
- +49 3641 220 501 Phone: Fax: +49 3641 220 502 ctz@asclepion.com e-mail:
- September 2001 Preparation date:
Device name: Laser System YellowStar
- YellowStar Common Name:
Classification
Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) Product code: GEX - Laser instrument, surgical, powered Panel: 79
Con Bio CuB-D10 Legally marketed:
Description: The Laser System YellowStar consists of a laser enclosure, fiber optic delivery system and an computer controlled treatment parameter interface.
- The laser system YellowStar intended for treatment of vascular Intended Use: and pigmented lesions.
- The specifications of the YellowStar are the same as or Comparison to: very similar to those of legally marketed lasers such as the ConBio CuB-D10 (K932723, K942934) and Metatech Vasculase (K883541, K903883)
1
- Performance data: None. The specifications and intended uses of the laser system YellowStar are the same or very similar to those of claimed predicate devices. Because of this , performance data were not required.
- The YellowStar is substantially equivalent to legally marketed CONCLUSION: devices.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Asclepion-Meditec AG c/o William Kelley Asclepion-Meditec, Inc. 2961 West MacArthur Boulevard, #133 Santa Ana, California 92704
Re: K013940
Trade Name: Laser System YellowStar Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: September 1, 2001 Received: November 29, 2001
Dear Mr. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave to rearly above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to may 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 20, 1970, the characteriance 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, (Act) that do not require space, subject to the general controls provisions of the Act. The general thereofs, maintons 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 rr your device is elassinos (tional 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 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 - Mr. William Kelly
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
V. Mark A. Millbern
elia 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
INDICATIONS FOR USE STATEMENT
K 613940 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _Laser System YellowStar
Indication For USE Statement:
(Per 21 CFR 801.109)
The YellowStar is intended for treatment of vascular and pigmented lesions.
The laser system YellowStar is restricted to sale to or use by licensed professionals in the United States.
Mark H. Milliken
Restorative Devices 013940
510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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