LASERSYSTEM BEAUTYSTAR 532 by ASCLEPION-MEDITEC AG

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ASCLEPION-MEDITEC AG Laser System BeautyStar 532:

Based on the provided 510(k) summary, no performance data or study information is included. The submission explicitly states:

"Performance data: None. The specifications and intended uses of the laser system BeautyStar 532 are the same as or very similar to those of claimed predicate devices. Because of this, performance data were not required."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. This device gained clearance based on substantial equivalence to predicate devices, meaning it was deemed as safe and effective as pre-existing devices without new clinical performance data being required.

Here's a breakdown of what can be extracted and why the other details are absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Safety endpoints)	Reported Device Performance (e.g., % (95% CI))
N/A - No performance data was required or submitted.	N/A - No performance data was required or submitted.

Explanation: The documentation explicitly states "Performance data: None." and that performance data was not required due to substantial equivalence to predicate devices. Therefore, there are no reported acceptance criteria or corresponding device performance metrics from a study in this submission.

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable, as no dedicated performance study was conducted.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device is a laser system, not an AI-powered diagnostic tool, and its clearance was based on substantial equivalence, not new performance data.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone (algorithm only) performance study was not done. This is a physical laser device, not an algorithm, and its clearance was based on substantial equivalence, not new performance data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable, as no dedicated performance study was conducted requiring ground truth.

8. The sample size for the training set:

Not applicable, as this is a physical medical device (laser system) and not an AI/ML algorithm that would typically have a "training set."

9. How the ground truth for the training set was established:

Not applicable, for the same reasons as point 8.

Summary

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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

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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.

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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
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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 _

Regulation Number and Section

§ 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.