(100 days)
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No
The document describes a laser device for soft tissue procedures and lipolysis. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The description focuses on the laser's technical specifications and intended uses.
Yes
The device is intended for "surgical incision, excision, vaporization, ablation, and coagulation of soft tissue" and "laser assisted lipolysis," which are therapeutic procedures.
No
The device is intended for surgical procedures such as incision, excision, vaporization, ablation, and coagulation of soft tissue, and laser-assisted lipolysis. These are therapeutic, not diagnostic, functions.
No
The device description clearly outlines a physical laser system with specific hardware components (Nd:YAG crystal rod, footswitch, power requirements, weight, and dimensions), indicating it is not a software-only device.
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 procedures on soft tissue within the body (in vivo). IVD devices are used to examine specimens taken from the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system designed for direct application to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a surgical laser intended for direct treatment of tissue, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength is further indicated for laser assisted lipolysis.
Product codes
GEX
Device Description
The Cynosure Smartlipo Multiwavelength laser with 1440nm wavelength is a Nd:YAG laser, having a ND:YAG crystal rod as a lasing medium. It is a laser with wavelengths of 1064 nm, 1320 nm, and 1440 nm.
Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD).
Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.
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
soft tissue, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
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
Nonclinical Performance Data: None
Clinical Performance Data: none
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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.
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K 091537
Submitter:
Contact:
Date Summary Prepared: Device Trade Name:
Common Name:
Classification Name:
Equivalent Device: Device Description:
Intended Use:
Comparison:
Nonclinical Performance Data: Clinical Performance Data: Conclusion:
Additional Information:
510(K) Summary Cynosure, Inc. 5 Carlisle Road SEP - 3 2009 Westford, MA 01886 Anthony Burns Regulatory Affairs Manager May 22, 2009 Cynosure Smartlipo Multiwavelength Laser with 1440mm wavelength
Medical Laser System
Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810
Cynosure Smartlipo Multiwavelength Laser
The Cynosure Smartlipo Multiwavelength laser with 1440nm wavelength is a Nd:YAG laser, having a ND:YAG crystal rod as a lasing medium. It is a laser with wavelengths of 1064 nm, 1320 nm, and 1440 nm.
Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD).
Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.
The SmartLipo Multiwavelength Laser with 1440nm wavelength is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo Multiwavelength with 1440nm wavelength is further indicated for laser assisted lipolysis.
The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength has the identical indications for use, the same principle of operation, and similar laser parameters as the predicate device.
None
none
The Cynosure Smartlipo Mutliwavelength Laser with 1440nm wavelength is a safe and effective device for the 'indications for use' specified.
none
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Image /page/1/Picture/0 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 resembling an eagle or bird in flight, with stylized lines representing its wings and body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Cynosure, Inc. % Mr. Anthony Burns Regulatory Affairs Manager 5 Carlisle Road Westford. Massachusetts 01886
SEP - 8 2009
Re: K091537
Trade/Device Name: Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength 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 2, 2009 Received: July 6, 2009
Dear Mr. Burns:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Anthony Burns
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.
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sturman P. Chapman
FR
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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510(k) Number (if known):
K 091537
Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength Device Name:
Indications For Use:
The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength is further indicated for laser assisted lipolysis.
OR Prescriptive Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Milke P. Oglin formkn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091537