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.

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.

AI/ML Overview

This submission is for a traditional 510(k) for a medical laser system. Traditional 510(k)s often rely on substantial equivalence to a predicate device rather than extensive clinical studies with specific performance criteria.

Therefore, the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are largely not applicable in the context of this specific 510(k) summary. The submission focuses on comparing the new device to an existing, legally marketed predicate device.

Here's a breakdown of why and what information can be inferred:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The submission does not provide acceptance criteria in the typical sense (e.g., sensitivity, specificity, accuracy targets). Instead, it relies on demonstrating that the new device has the "same indications for use, the same principle of operation, and the same laser parameters as the predicate device(s)." This inherently means the "performance" should be equivalent to the predicate, as its safety and effectiveness have already been established.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No test set or clinical study exploring specific performance metrics is mentioned. The submission is a comparison to a predicate, not a de novo performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No test set requiring ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set requiring adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a laser system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No specific ground truth is established for the device itself in this submission. The "ground truth" for regulatory equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set

Not Applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not Applicable. No training set is mentioned.

Conclusion based on the provided document:

The Cynosure Smartlipo MPX Laser with SmartSense C Module establishes substantial equivalence to its predicate device (The Cynosure YAG Family laser) by stating:

Same indications for use: Surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including laser-assisted lipolysis).
Same principle of operation: Nd:YAG laser with 1064 nm and 1320 nm wavelengths.
Same laser parameters.

The 510(k) summary explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none" for the new device. This confirms that the approach was squarely based on substantial equivalence rather than new clinical trials demonstrating specific performance metrics.

The FDA's decision letter (K083379) confirms that the device was found "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls. This means the device met the regulatory acceptance criteria by demonstrating similarity to an already approved device regarding its intended use, technology, and performance characteristics, without needing to conduct new, explicit performance studies.

Summary

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Submitter:

Contact:

Date Summary Prepared: Device Trade Name:

Common Name:

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Equivalent Device:

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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

The Cynosure Smartlipo MPX Laser with SmartSense C Module is a safe and effective device for the 'indications for use' specified. none

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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.

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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:

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

Regulation Number and Section

§ 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.