(26 days)
Ceralas D 980
Not Found
No
The summary describes a diode laser system for soft tissue procedures and does not mention any AI or ML capabilities.
Yes
The device is intended for surgical procedures like incision, excision, vaporization, and coagulation of soft tissue, which are therapeutic interventions.
No
The device summary indicates the QuadroStar 980 Laser System is used for surgical procedures such as incision, excision, vaporization, and coagulation, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "diode laser system" emitting a laser beam, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for direct interaction with soft tissue during surgical procedures (incision, excision, vaporization, etc.). This is a therapeutic and surgical device, not a diagnostic one.
- Device Description: The description confirms it's a laser system emitting light for surgical purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to provide information about a patient's health status through the examination of these samples.
Therefore, the QuadroStar 980 Laser System falls under the category of a surgical/therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QuadroStar 980 Laser System is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
Product codes
GEX, OCL
Device Description
The QuadroStar 980 is a diode laser system emitting a laser beam at a wavelength of 980 nm with a maximum power of 25 W.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery, cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
Ceralas D 980
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
MAR 2 () 2006
510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH MeDioStar miXT Laser System
This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH QuadroStar 980 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: | January 31st, 2006 |
| Device Name: | QuadroStar 980 |
| Common Name: | QuadroStar 980 |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.481 |
| Equivalent Device: | Ceralas D 980 |
| Device Description: | The QuadroStar 980 is a diode laser system emitting a laser
beam at a wavelength of 980 nm with a maximum power
of 25 W. |
| Intended Use: | Delivery of laser light to soft tissue in the contact or non-
contact mode during surgical procedures, including via
endoscopes, introducers or catheters. The QuadroStar 980 is
generally indicated for incision, excision, vaporization,
ablation, hemostasis or coagulation of soft tissue in ear,
nose and throat and oral surgery (otolaryngology), dental
procedures, arthroscopy, gastroenterology, general surgery,
dermatology, plastic surgery, podiatry, urology, gynecology,
neurosurgery (peripheral nervous system), pulmonary
surgery cardiothoracic surgery. This QuadroStar 980 is |
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specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue). The QuadroStar 980 Laser System is substantially equivalent Comparison to: to the Ceralas D 980 Laser System, 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. None Nonclinical Performance Data: Clinical Performance Data: None The QuadroStar 980 Laser System is another safe and Conclusion: effective device for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
Additional Information :
None
- FEB. 2016 Le vole (* 0 : 1 1 : 1 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 2 1 :
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asclepion Laser Technologies GmbH c/o Mr. Reinhard Thieme Goeschwitzerstrasse Str. 51-52 07745 Jena, Germany
Re: K060459
Trade/Device Name: QuadroStar 980 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: February 14, 2006 Received: February 22, 2006
Dear Mr. Thieme:
This letter corrects our substantially equivalent letter of March 20, 2006.
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 (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 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.
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Page 2 - Mr. Reinhard Thieme
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 reguirements as set forth in the quality systems (OS) 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 continue 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular 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): _KO6 DYS 9
Device Name: QuadroStar 980 Laser System
Indications for Use:
The QuadroStar 980 Laser System is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
× 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)
of Device Evaluation (ODE) Conci Division of General, Restorative, and Neurological Devices
510(k) Number_ko60459
14.FEB.2006 00 00112