(302 days)
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No
The provided text describes a laser surgical device and its intended uses across various medical specialties. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The description focuses solely on the physical device and its surgical applications.
Yes.
The device is indicated for surgical applications requiring the vaporization, incision, excision, cutting, and hemostasis of soft tissue, which are procedures that treat or alleviate a disease or condition.
No
The device is indicated for surgical applications involving vaporization, incision, excision, cutting, and hemostasis of soft tissue, primarily for therapeutic purposes rather than diagnosis.
No
The device description explicitly mentions "fiber delivery systems and accessories used to deliver laser energy," which are hardware components. The intended use also describes surgical applications requiring physical interaction with tissue (vaporization, incision, etc.), which is performed by hardware.
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 device used for surgical applications on soft tissue within the body. This involves direct interaction with the patient's tissues for therapeutic or surgical purposes.
- Lack of IVD Characteristics: An IVD is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of the Lasemar 800, 1000, and 1500 does not mention any analysis of bodily fluids, tissues, or other specimens outside the body.
The device is a surgical laser system used for procedures like vaporization, incision, and hemostasis directly on the patient. This falls under the category of a therapeutic or surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Lasemar 800, Lasemar 1000, Lasemar 1500 (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for: surgical applications requiring the vaporization, incision, excition, cutting and hemostation, cutting and hemostasis, or specialistion of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracio Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedias, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Spinel Radiology, Endovascular coagulation, Oral Surgery, Dental procedures and Laser Assisted Linolysis.
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 6 2010
Eufoton S.R.L. % Mr. Paolo Cossich Via Flavia 23/1 Trieste, Italy 34148
Re: K092860
Trade/Device Name: Lasemar 800, 1000, 1500 Regulation Number: 21 CFR 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: July 09, 2010
Received: July 15, 2010
Dear Mr. Cossich:
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, Or ug 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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, FIDA 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
1
Page 2 - Mr. Paolo Cossich
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Yavinal S. Chapman
FOR M:
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2
Indications for Use
510(k) Number (if known): K 092860
DEVICE NAME:
Lasemar 800, Lasemar 1000, Lasemar 1500
Indications for use
The Lasemar 800, Lasemar 1000, Lasemar 1500 (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for :surgical applications requiring the vaporization, incision, excition, cutting and hemostation, cutting and hemostasis, or specialistion of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracion who endoscopic equipment for medical
Aesthelics including: Urology, Thoracio Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedias, Podiatry, Arthroscopy, Spinal Surgery,
Ophthalmology, Orthopedics, Podiator, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Spinel Radiology, Endovascular coagulation, Oral Surgery, Dental procedures and Laser
Assisted Linolysis Assisted Lipolysis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
(Division Sign-Off) Division of Surgisal, Orthopedic, and Restorative Devices
510(k) Number K092860