(28 days)
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No
The document describes a laser device for soft tissue procedures and lipolysis, with no mention of AI or ML technologies in the intended use, device description, or specific sections for AI/ML mentions.
Yes
The device is intended for surgical procedures such as incision, excision, vaporization, and coagulation of soft tissue, as well as laser-assisted lipolysis, which are therapeutic interventions.
No
The device description and intended use indicate that the Cynosure Smartlipo MPX Laser is used for surgical procedures like incision, excision, vaporization, ablation, coagulation, and lipolysis of soft tissue. These are therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly states it is a physical laser system with a specific weight, dimensions, and electrical requirements, indicating it is a hardware 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 surgical laser for the incision, excision, vaporization, ablation, and coagulation of soft tissue, and laser assisted lipolysis. These are all procedures performed directly on the patient's body.
- Device Description: The description details a laser system with specific wavelengths and physical characteristics, designed for surgical applications.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health. The provided information does not mention any analysis of biological samples or diagnostic purposes.
Therefore, the Cynosure Smartlipo MPX Laser is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Cynosure Smartlipo MPX Laser 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 MPX Laser is futher indicated for laser assisted lipolysis.
Product codes
GEX
Device Description
The Cynosure Smartlipo MPX laser with SmartSense C Module is a Nd: YAG laser, having a ND: YAG crystal rod as a lasing medium. It is a laser with a wavelength of 1064 nm and 1320 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 includes 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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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. K083379 5 Carlisle Road Westford, MA 01886 George Cho Senior Vice President of Medical Technology November 13. 2008 Cynosure Smartlipo MPX Laser
Medical Laser System
Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810
The Cynosure YAG Family laser
The Cynosure Smartlipo MPX laser with SmartSense C Module is a Nd: YAG laser, having a ND: YAG crystal rod as a lasing medium. It is a laser with a wavelength of 1064 nm and 1320 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 MPX Laser 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 SmartLipo is further indicated for laser assisted lipolysis.
The Cynosure Smartlipo MPX Laser with SmartSense C Module has the same indications for use, the same principle of operation, and the same laser parameters as the predicate device(s).
none
none
The Cynosure Smartlipo MPX Laser with SmartSense C Module is a safe and effective device for the 'indications for use' specified. none
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cynosure, Inc. % Mr. George Cho Sr. Vice President 5 Carlisle Westford, Massachusetts 01886
DEC 1 2 2008
Re: K083379
Trade/Device Name: Cynosure Smartlipo MPX Laser with SmartSense C Module 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: November 13, 2008 Received: November 14, 2008
Dear Mr. Cho:
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 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.
2
Page 2 - Mr. George Cho
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N. Millman
- Mark N. Melkerson 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): KO8 3379
Device Name: Cynosure Smartlipo MPX Laser with SmartSense C Module Indications For Use:
The Cynosure Smartlipo MPX Laser 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 MPX Laser is futher indicated for laser assisted lipolysis.
Prescriptive Use X OR (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)
Net RR. Roda for rent
Division of General, Restorative, and Neurological Devices
510(k) Number K083379