(14 days)
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No
The document describes a laser device for soft tissue procedures and laser-assisted lipolysis. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The description focuses on the laser's physical characteristics 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 interventions.
No
The device is described as a surgical laser intended for the incision, excision, vaporization, ablation, and coagulation of soft tissue, and laser-assisted lipolysis. These are therapeutic, not diagnostic, functions.
No
The device description clearly indicates it is a physical laser system with hardware components (Nd:YAG crystal rod, footswitch, specific dimensions and weight, electrical requirements). It is not solely software.
Based on the provided information, the Cynosure Smartlipo Multiwavelength Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue, and for laser assisted lipolysis. These are all procedures performed on the patient's body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a laser system designed for surgical procedures.
- 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.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cynosure Smartlipo Multiwavelength Laser's function is to directly interact with and modify soft tissue within the body.
N/A
Intended Use / Indications for Use
The SmartLipo Multiwavelength Laser 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 is further indicated for laser assisted lipolysis.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cynosure Smartlipo Multiwavelength laser 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, 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
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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)
Nonclinical Performance Data: none
Clinical Performance Data: none
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.
The Cynosure YAG Family laser
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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| 510(K) Summary | |
|---|---|
| Submitter: | Cynosure, Inc. |
| 5 Carlisle Road | |
| Westford, MA 01886 | |
| Contact: | George Cho |
| Senior Vice President of Medical Technology | |
| Date Summary Prepared: | January 16, 2008 |
| Device Trade Name: | Cynosure Smartlipo Multiwavelength Laser |
| JAN 31 2008 | |
| 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 Multiwavelength laser 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 Multiwavelength Laser 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 is further indicated for laser assisted lipolysis. | |
| Comparison: | The Cynosure Smartlipo Multiwavelength Laser has the equivalent |
| 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 Mutliwavelength Laser is a safe and effective |
| device for the 'indications for use' specified. | |
| Additional Information: | none |
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being. The logo is presented in black and white.
Public Health Service
JAN 31 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cynosure, Inc. % Mr. George Cho Senior Vice President, Medical Technology 5 Carlisle Road Westford, Massachusetts 01886
Re: K080121 Trade/Device Name: Cynosure Smartlipo Multiwavelength Laser Regulatory Number: 21 CFR 878.4810 Regulatory Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 16, 2008 Received: January 17, 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
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Page 2 - Mr. George Cho
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.
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 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 yours.
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):
Cynosure Smartlipo Multiwavelength Laser Device Name:
Indications For Use:
The Cynosure Smartlipo Multiwavelength 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 Multiwavelength 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)
(Division Sign-Off
Division of General, Restorative, and Neurological Devices
Number L050121