(26 days)
The QuadroStar 532 is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.
The QuadroStar 532 Laser System is a frequency doubled diode - pumped solid state laser (LBO) . It consists a laser enclosure and optic delivery system (fiber bundle and handpiece).
The provided text is a 510(k) summary for a laser system (QuadroStar 532). It explicitly states:
- "Nonclinical Performance Data: None"
- "Clinical Performance Data: None"
This indicates that no clinical or nonclinical studies were performed to prove the device meets acceptance criteria. The submission relies on substantial equivalence to a predicate device (BeautyStar 532 Laser System) based on similar principles of operation, wavelength, and power range for the same indications for use.
Therefore, the following information cannot be extracted from the provided text, as no such studies were conducted or reported:
- Table of acceptance criteria and reported device performance: Not applicable as no performance data is presented.
- Sample size used for the test set and data provenance: No test set information available.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth established from experts for a test set.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was done.
- Standalone (algorithm only) performance study: Not applicable as this is a physical laser device, not an algorithm.
- Type of ground truth used: Not applicable as no studies were performed.
- Sample size for the training set: Not applicable as no training set was used (e.g., for an AI/ML device).
- How the ground truth for the training set was established: Not applicable.
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510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH MeDioStar miXT Laser System
12040457
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH QuadroStar 532 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 GmbHGoeschwitzer Str. 51-5207745 Jena, Germany |
|---|---|
| Contact Person: | Mr Reinhard ThiemeQuality Assurance andInternational Regulatory Affairs |
| Phone: | +49 3641 220 211 |
| Fax: | +49 3641 220 322 |
| e-mail: | reinhard.thieme@asclepion.com |
| Preparation Date: | January 31st, 2006 |
| Device Name: | QuadroStar 532 |
| Common Name: | QuadroStar 532 |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.481 |
| Equivalent Device: | BeautyStar 532 |
| Device Description: | The QuadroStar 532 Laser System is a frequency doubleddiode - pumped solid state laser (LBO) . It consists a laserenclosure and optic delivery system (fiber bundle andhandpiece). |
| Intended Use: | The QuadroStar 532 is intended for vaporization andphotocoagulation of vascular and pigmented lesions in softtissue. |
| Comparison to: | The QuadroStar 532 Laser System is substantially equivalentto the BeautyStar 532 Laser System, with the sameprinciples of operation, the same wavelength andessentially the same power range as the predicate device forthe same indications for uses. |
| 14.FEB.2006 0000100 |
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| Nonclinical Performance Data: | None |
|---|---|
| Clinical Performance Data: | None |
| Conclusion: | The QuadroStar 532 Laser System is anothersafe and effective device for vaporization andphotocoagulation of vascular and pigmentedlesions in soft tissue. |
Additional Information :
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None
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2006
Asclepion Laser Technologies GmbH c/o Mr. Reinhard Thieme Goeschwitzerstrasse Str. 51-52 07745 Jena, Germany
Re: K060457
Trade/Device Name: QuadroStar 532 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: February 14, 2006 Received: February 22, 2006
Dear Mr. Thieme:
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.
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
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Page 2 - Mr. Reinhard Thieme
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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
el. Mel.
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: QuadroStar 532 Laser System
Indications for Use:
The QuadroStar 532 Laser System is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.
メ 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)
elgmee
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_ko60457
Page 1 of 1
14.FEB.2006 0000111
§ 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.