CYNOSURE SMARTLIPO MPX LASER by CYNOSURE, INC.

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

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.

AI/ML Overview

This document does not describe acceptance criteria for a device's performance or a study proving that the device meets such criteria. Instead, it is a 510(k) premarket notification summary and an FDA clearance letter for the Cynosure Smartlipo MPX Laser with SmartSense T Module.

The key information provided relates to the device's regulatory submission and substantial equivalence to a predicate device, rather than detailed performance study results.

Here's an analysis based on the provided text, addressing your questions where possible:

A table of acceptance criteria and the reported device performance:
- N/A. The document explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This indicates that no specific performance criteria or studies proving performance against those criteria were submitted or are reported in this document for the Smartlipo MPX Laser with SmartSense T Module. The clearance is based on substantial equivalence to a predicate device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No test set data or clinical study information is provided.
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):
- N/A. No ground truth establishment is described as there are no performance studies reported.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or adjudication method is described.
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:
- N/A. This device is a laser system, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study related to human readers and AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not appear to involve an algorithm or AI component for standalone performance evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No ground truth is mentioned as no performance studies are reported.
The sample size for the training set:
- N/A. No training set is mentioned as no algorithm or AI component is described.
How the ground truth for the training set was established:
- N/A. No ground truth for a training set is relevant or described here.

Conclusion from the document:

The Cynosure Smartlipo MPX Laser with SmartSense T Module received FDA clearance (K083795) based on its substantial equivalence to predicate devices (specifically, the Cynosure YAG Family laser). The submission explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This means that the regulatory decision was made without new performance studies, relying instead on the established safety and effectiveness of the legally marketed predicate devices with the same indications for use, principle of operation, and laser parameters.

Summary

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	Submitter	Cynosure, Inc5 Carlisle RoadWestford, MA 01886	JAN 21 2009K083795
	Contact	George ChoSenior 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, laser79-GEX21 CFR 878 4810
	Equivalent Device	The Cynosure YAG Family laser
	Device Description	The Cynosure Smartlipo MPX laser with SmartSense T Module is aNd YAG laser, having a ND YAG crystal rod as a lasing medium Itis a laser with a wavelength of 1064 nm and 1320 nm
		Laser activation is by footswitch Overall weight of the laser is285lbs, 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 Softtissue includes skin, cutaneous tissue, subcutaneous tissue, striated andsmooth tissue, muscle, cartilage meniscus, mucous membrane, lymphvessels and nodes, organs and glands The SmartLipo is furtherindicated for laser assisted lipolysis
	Comparison	The Cynosure Smartlipo MPX Laser with SmartSense T Module hasthe same indications for use, the same principle of operation, and thesame 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 asafe 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 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

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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 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

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510(k) Number (if known)

Cynosure Smartlipo MPX Laser with SmartSense T Module Device Name

Indications For Use

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

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.