(88 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on hardware components and a computer-controlled interface for treatment parameters, which is standard for medical lasers and does not inherently imply AI/ML.
Yes
The device is intended for "Vaporization and Photocoagulation of vascular and pigmented lesions," which are therapeutic procedures.
No.
The device is described as a laser system intended for "Vaporization and Photocoagulation of vascular and pigmented lesions," which are treatment modalities, not diagnostic ones. There is no mention of the device being used to identify, detect, or characterize a disease or condition.
No
The device description explicitly states it consists of a laser enclosure, fiber optic delivery system, and a computer-controlled interface, indicating it is a hardware system with software control, not a software-only device.
Based on the provided information, the BeautyStar 532 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "Vaporization and Photocoagulation of vascular and pigmented lesions in soft tissue." This describes a therapeutic procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description mentions a laser enclosure, fiber optic delivery system, and computer-controlled interface. These are components of a device used for direct treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests in vitro (outside the body), or providing diagnostic information based on sample analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BeautyStar 532's function is to treat tissue directly using laser energy.
N/A
Intended Use / Indications for Use
The Laser system BeautyStar 532 intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.
Product codes
GEX
Device Description
The Laser System BeautyStar 532 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
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
restricted to sale to or use by licensed professionals in the United States.
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 BeautyStar 532 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)
K990174, K951034, K010885, K964074, K002296, K020071
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KO21975 510(k) SUMMARY ASCLEPION-MEDITEC AG Laser Svstem BeautyStar 532
This 510(k) summary of safety and effectiveness for the ASCLEPION-MEDITEC AG Laser System BeautyStar 532 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: Address: Goeschwitzer Strasse 51-52 07745 Jena, Germany Contact Person: Dr. Dirk Colditz Vice President Operations and International Requlatory Affairs +49 3641 220 501 Phone: +49 3641 220 502 Fax: e-mail: ctz@asclepion.com Mai 23″d, 2002 Preparation date: Laser System BeautyStar 532 Device name: Common Name: BeautyStar 532 Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) Product code: GEX - Laser instrument, surqical, powered Panel: 79 in the European Community based on CE-Mark Legally marketed: Description: The Laser System BeautyStar 532 consists of a laser enclosure. fiber optic delivery system and an computer controlled treatment parameter interface. Intended Use: The laser system BeautyStar 532 intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue. Comparison to: The specifications of the BeautyStar 532 are the same as or very similar to those of legally marketed lasers such as the HGM Atlas-Elite, Model E-80, Corium 200/400 (K990174), Laserscope
1
Aura (K951034), Medart Corp. MedArt 470(K010885), Iridex Corp. DioLite 532 (K964074, Ceramoptec Ceralase G15(K002296) and Quantel Medical Viridis Derm (K020071)
- Performance data: None. The specifications and intended uses of the laser system BeautyStar 532 are the same or very similar to those of claimed predicate devices. Because of this , performance data were not required.
- The BeautyStar 532 is substantially equivalent to legally CONCLUSION: marketed devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asclepion-Meditec AG William Kellev c/o Asclepion-Meditec, Inc. 8884 Warner Avenue, Suite 167 Fountain Valley, California 92708
SEP 1 3 2002
Re: K021975
Trade/Device Name: Laser System BeautyStar 532 Regulation Number: 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: May 20, 2002 Received: June 17, 2002
Dear Mr. Kelley:
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. Insting 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 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.
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Page 2 – Mr. William Kelley
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 vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Celia 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
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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K021975 |
|---|---|
| --------------------------- | --------- |
Device Name: Laser System BeautyStar 532
Indication For USE Statement:
The BeautyStar 532 is intended for Vaporization and Photocoagulation of vascular and pigmented lesions in soft tissue.
The laser system BeautyStar is restricted to sale to or use by licensed professionals in the United States.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
er-The-Counter Use
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number _