(30 days)
Not Found
Not Found
No
The document describes a laser device for soft tissue procedures and laser-assisted lipolysis, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
Yes
The indications for use state surgical incision, excision, vaporization, ablation, and coagulation of soft tissue, as well as laser-assisted lipolysis, which are therapeutic interventions.
No
The "Intended Use / Indications for Use" section describes the device's function as being for surgical procedures (incision, excision, vaporization, ablation, coagulation, and laser-assisted lipolysis) of soft tissue, rather than for diagnosing conditions.
No
The device description clearly states it is a Nd YAG laser with a physical weight and dimensions, indicating it is a hardware device.
Based on the provided information, the Cynosure Smartlipo MPX Laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device for surgical procedures on soft tissue (incision, excision, vaporization, ablation, and coagulation) and laser-assisted lipolysis. These are all procedures performed directly on a living patient.
- Device Description: The description details a laser system used for delivering energy to tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. The provided information does not mention any analysis of specimens or diagnostic purposes.
Therefore, the Cynosure Smartlipo MPX Laser is a surgical laser device, not an IVD.
N/A
Intended Use / Indications for Use
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
Product codes
GEX
Device Description
The Cynosure Smartlipo MPX laser with SmartSense T 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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)
Not Found
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
| | Submitter | Cynosure, Inc
5 Carlisle Road
Westford, MA 01886 | JAN 21 2009
K083795 |
|--|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | Contact | George Cho
Senior Vice President of Medical Technology | |
| | Date Summary Prepared | December 19, 2008 | |
| | Device Trade Name | Cynosure Smartlipo MPX Laser | |
| | Common Name | Medical Laser System | |
| | Classification Name | Instrument, surgical, powered, laser
79-GEX
21 CFR 878 4810 | |
| | Equivalent Device | The Cynosure YAG Family laser | |
| | Device Description | The Cynosure Smartlipo MPX laser with SmartSense T 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 | |
| | Intended Use | 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 | |
| | Comparison | The Cynosure Smartlipo MPX Laser with SmartSense T Module has
the same indications for use, the same principle of operation, and the
same laser parameters as the predicate device(s) | |
| | Nonclinical Performance Data | none | |
| | Clinical Performance Data | none | |
| | Conclusion | The Cynosure Smartlipo MPX Laser with SmartSense T Module is a
safe and effective device for the 'indications for use' specified | |
| | Additional Information | none | |
1
Image /page/1/Picture/1 description: The image shows a black and white seal of the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2009
Cynosure, Inc % Mr George Cho Senior Vice President 5 Carlisle Road Westford, Massachusetts 01886
Re K083795
Trade/Device Name Cynosure Smarthpo MPX Laser with SmartSense T 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 December 19, 2008 Received December 22, 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, lusting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration
If your device is classified (see above) into ether class II (Special Controls) or class III (PMA), t 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 Complance 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 B1ometric'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 Surveyllance 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 M. Milburn
Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known)
Cynosure Smartlipo MPX Laser with SmartSense T Module Device Name
Indications For Use
The Cynosure Smartlıpo 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, cartılage meniscus. mucous membrane, lymph vessels and nodes, organs and glands The Cynosure Smartlıpo MPX Laser is futher ındıcated for laser assısted lıpolysis
Prescriptive Use X 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)
Daind Krone for MXM 1/21/2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083795