The 25mm, and 30mm handpieces provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The massage device is intended to provide a temporary reduction in the appearance of cellulite

The following surgical modes are applicable to the generator:

Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed

Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control. epistaxis treatment, turbinate shrinkage. skin incisions, biopsy, cysts, abscesses. tumors. cosmetic repairs, development of skin flaps. skin tags and blepharoplasty.

Blended Cutting and Coagulation: submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP). myringotomy with effective hemorrhage control. epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids. keratosis, verrucae, basal cell carcinoma. nevi. fistulas. epithelidma. cosmetic repairs. cysts. abscesses. and development of skin flaps.

Fulguration: basal cell carcinoma. papilloma. cyst destruction, tumors. verrucae, hemostasis.

Bipolar: pinpoint precise coagulation. pinpoint hemostasis in any, field (wet or dry). snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP). myringotomy with effective hemorrhage control. epistaxis treatment and turbinate shrinkage

Device Description

The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and surgical procedures. The intended action is achieved through application of radiofrequency energy to the patient which results in minimization of heat dissipation and cellular alteration. Output of energy is controlled via the guided user interface (GUI) and the foot and/or hand-switch.

The TempSure generator has been upgraded to include additional surgical modes – Cut, Bipolar, Fulgurate, and Blend, along with the existing Coag. The power of the device for Surgical applications is a maximum of 300W. There have been no changes to the Smart Handpiece treatment with temperature sensitive handpieces.

TempSure system is used with the same existing Ellman electrosurgical accessories.

The TempSure™ System includes:
• TempSure™ Generator
• Temperature Sensing Handpieces
• IEC Power Cord
• Footswitch
• Disposable/Reusable Neutral Pad
• Surgical Fingerswitch/Foot Controlled Handpieces
• Monopolar Cables
• Disposable/Reusable Electrodes, Forceps

AI/ML Overview

The provided document is a 510(k) summary for the Cynosure TempSure System, an electrosurgical device. It primarily details the device's substantial equivalence to predicate devices based on non-clinical testing. It does not describe an AI/ML-driven medical device, nor does it involve the use of AI assistance for human readers, ground truth establishment by experts, or MRMC studies.

Therefore, many of the requested details, such as acceptance criteria for AI performance metrics (e.g., sensitivity, specificity), sample sizes for AI test sets, expert consensus for ground truth, adjudication methods, MRMC studies, or standalone AI performance, are not applicable to this submission.

The document focuses on demonstrating substantial equivalence through:

Indications for Use (IFU) Comparison: Showing the TempSure System has similar IFUs to legally marketed predicate devices.
Technological Characteristics Comparison: Highlighting similarities in energy type, modality, power output, etc.
Performance Testing (Non-Clinical): Primarily focusing on thermal effects on tissue and electrical safety/EMC.

Below is an attempt to address the relevant points based only on the provided text, while explicitly stating when information is N/A or not present.

Acceptance Criteria and Study for Cynosure TempSure System (K182365)

This submission is for an electrosurgical device and relies on showing substantial equivalence to predicate devices through non-clinical performance data and comparison of technological characteristics. It does not involve AI/ML.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" for performance metrics in the way one might for an AI/ML device (e.g., minimum sensitivity). Instead, the acceptance is based on demonstrating the similarity of the device's performance (specifically the thermally affected zone) and safety characteristics to the predicate devices.

Acceptance Criteria (Implied / Demonstrated through comparison):

Thermal Effects on Tissue: The Thermally Affected Zone (TAZ) created by the TempSure system should be similar to that created by the predicate devices (Surgitron and ForceTriad).
Electrical Safety & Electromagnetic Compatibility (EMC): The device must satisfy the requirements of relevant international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).

Reported Device Performance (as summarized in the document):

Criterion / Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Thermal Effects on Tissue	TAZ of TempSure should be similar to predicate devices.	Testing was performed on ex-vivo tissue samples (liver, kidney, and muscle) in triplicate at three power settings. The TempSure device's TAZ was compared to the ForceTriad and Surgitron devices. Conclusion: "The Thermal Effects on Tissue test showed that the thermally affected zone created by the TempSure™ device was similar to that created by the predicate devices, Surgitron and ForceTriad, in ex-vivo tissue testing. Despite their difference in maximum output power, the devices created a similar TAZ and therefore the devices can be considered substantially equivalent."
Electrical Safety and EMC	Device must comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 standards.	Conclusion: "In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards." (Specific test results or pass/fail rates are not provided in this summary, but the general compliance is stated).
General Safety and Effectiveness	Device should be safe and effective and perform as well as legally marketed predicate devices.	Overall Conclusion: "The nonclinical tests demonstrate that the TempSure™ system is safe and effective and performs as well as the legally marketed predicate devices."

2. Sample size used for the test set and the data provenance

Test Set (for Thermal Effects on Tissue): Measurements were taken "in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings." This implies a total of 27 measurements for the TempSure device and 27 for each predicate device (3 tissues * 3 power settings * 3 replicates).
Data Provenance: The document does not specify the country of origin for the ex-vivo tissue samples or if the testing was prospective or retrospective. Given it's ex-vivo tissue, the notion of retrospective/prospective typically applies to patient data, which is not what was used here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This applies to AI/ML systems where human experts establish ground truth. For this electrosurgical device, "ground truth" for performance was based on physical measurements (Thermally Affected Zone, electrical parameters) rather than expert interpretation of medical images or patient outcomes data.

4. Adjudication method for the test set

N/A. Adjudication methods (e.g., 2+1, 3+1) are relevant for establishing ground truth from multiple human readers/experts, which is not applicable to the performance testing described for this electrosurgical device.

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

N/A. No clinical tests were submitted; therefore, no MRMC study, human reader improvement analysis, or AI assistance was performed or assessed.

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

N/A. No AI algorithm is involved with this device. The device itself (radiofrequency generator) is the "standalone" entity tested for its physical performance.

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

Physical Measurements / Bench Testing Standards. The "ground truth" for evaluating the device's performance was based on:
- Direct measurement of the Thermally Affected Zone (TAZ) in ex-vivo tissue.
- Compliance with established electrical safety and electromagnetic compatibility standards (IEC 60601 series). This is akin to meeting engineering specifications rather than clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

N/A. This device does not use machine learning, so there is no "training set."

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

N/A. Not applicable, as there is no training set for an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 24, 2018

Cynosure, Inc Amy Tannenbaum Regulatory Affairs Specialist III 5 Carlisle Road Westford, Massachusetts 01886

Re: K182365

Trade/Device Name: TempSure System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 29, 2018 Received: August 30, 2018

Dear Amy Tannenbaum:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entiled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson For Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182365

Device Name TempSure System

Indications for Use (Describe)

The 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.

The massage device is intended to provide a temporary reduction in the appearance of cellulite

The following surgical modes are applicable to the generator:

Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed

Fulguration: basal cell carcinoma. papilloma. cyst destruction, tumors. verrucae, hemostasis.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary for Cynosure TempSure System

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

807.92(a)(1) Submitter Information
Applicant	Cynosure, Inc
Address	5 Carlisle Road, Westford MA, 01886
Phone Number	781-993-2454
Fax Number	978-256-6556
Establishment Registration Number	1222993
Contact Person	Amy Tannenbaum
Preparation Date	August 29, 2018
807.92(a)(2) Name of Device
Trade or Proprietary Name	TempSure System
Common or Usual Name	Surgical RF Generator
Classification Name	Electrosurgical, Cutting / Coagulation / Accessories
Classification Panel	General & Plastic Surgery
Regulation	21 CFR 878.4400
Regulatory Class	II
Product Code(s)	GEI, PBX
807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed
Predicate Devices	Cynosure TempSure (K171262)Cynosure dba Ellman Surgitron 4.0 Dual RF S5 - Pelleve (K123366)ValleyLab ForceTriad (K051644)
807.92(a)(4) Device Description
	The Cynosure TempSure™ System is a radiofrequency generator witha variety of applications both aesthetic and surgical procedures. Theintended action is achieved through application of radiofrequencyenergy to the patient which results in minimization of heat dissipationand cellular alteration. Output of energy is controlled via the guideduser interface (GUI) and the foot and/or hand-switch.The TempSure generator has been upgraded to include additionalsurgical modes – Cut, Bipolar, Fulgurate, and Blend, along with theexisting Coag. The power of the device for Surgical applications is amaximum of 300W. There have been no changes to the SmartHandpiece treatment with temperature sensitive handpieces.
	TempSure system is used with the same existing Ellman
	electrosurgical accessories.
	The TempSure™ System includes:
	TempSure™ Generator•
	Temperature Sensing Handpieces•
	IEC Power Cord•
	Footswitch•
	Disposable/Reusable Neutral Pad•
	Surgical Fingerswitch/Foot Controlled Handpieces•
	Monopolar Cables•
	Disposable/Reusable Electrodes, Forceps•
807.92(a)(5) Intended Use of the Device
	The TempSure System has the following indications for use:
	The 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
	The 25mm, and 30mm handpieces provide heating for the purpose ofelevating tissue temperature for selected medical conditions such astemporary relief of pain, muscle spasms, and increase in localcirculation.
	The massage device is intended to provide a temporary reduction inthe appearance of cellulite
	The following surgical modes are applicable to the generator:
	Coagulation/Hemostasis: General surgical procedures includingurologic, thoracic, plastic, reconstructive, and gynecologicalprocedures where electrosurgical coagulation of tissue is performed
	Cutting: snoring. submucosal palatal shrinkage, traditionaluvulopalatoplasty (RAUP), myringotomy with effective hemorrhagecontrol. epistaxis treatment, turbinate shrinkage. skin incisions,biopsy, cysts, abscesses. tumors. cosmetic repairs, development of'skin flaps. skin tags and blepharoplasty.
	Blended Cutting and Coagulation: snoring. submucosal palatalshrinkage, traditional uvulopalatoplasty (RAUP). myringotomy witheffective hemorrhage control. epistaxis treatment, turbinate shrinkage,skin tags, papilloma keloids. keratosis, verrucae, basal cell carcinoma.
nevi. fistulas. epithelidma. cosmetic repairs. cysts. abscesses. anddevelopment of skin flaps.
Fulguration: basal cell carcinoma. papilloma. cyst destruction,tumors. verrucae, hemostasis.
Bipolar: pinpoint precise coagulation. pinpoint hemostasis in any,field (wet or dry). snoring. submucosal palatal shrinkage, traditionaluvulopalatoplasty (RAUP). myringotomy with effective hemorrhagecontrol. epistaxis treatment and turbinate shrinkage

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807.92(b)(1) Non-clinical tests submitted

The following non-clinical tests have been included in this 510k submission in determination of substantial equivalence between the test device and the referenced predicates. These tests have been conducted in accordance with the FDA Guidance "Premarket Notification 510k Submissions for electrosurgical Devices for General Surgery" - Section XI. Performance Data. E - System Testing, Thermal Effects on Tissue. See Section 18 - Performance Testing, Bench. A brief summary is provided below.

Thermal Effects on Tissue

Testing was performed on ex-vivo tissue samples to compare the thermally affected zone (TAZ) of the TempSure and predicate devices. Measurements were taken in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings. For each tissue and power setting combination, the TempSure and the predicate device(s) were compared. This test shows that the TempSure is substantially equivalent to the ForceTriad and Surgitron devices.

Electromagnetic Compatibility and Electrical Safety

Electrical safety testing for the Cynosure TempSure System was also completed to prove the safe use of the device. These test reports are provided in accordance with FDA Guidance "Premarket Notification 510k Submissions for Electrosurgical Devices for General Surgery" - Section XII -Electrical Safety and Electromagnetic Compatibility". The following test reports are available in Section 17 - Electromagnetic Compatibility and Electrical Safety.

IEC 60601-1, Medical Electrical Equipment Part 1: General requirements for basic safety . and essential performances
IEC 60601-1-2, Medical Electrical Equipment Part 1 -2: General requirements for basic ● safety and essential performance - Collateral standard: Electromagnetic disturbances requirements and tests
IEC 60601-2-2, Medical electrical equipment Part 2 -2: Particular requirements for the basic ● safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

807.92(b)(2) Clinical tests submitted – N/A - No clinical tests submitted

807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted

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The nonclinical tests demonstrate that the TempSure™ system is safe and effective and performs as well as the legally marketed predicate devices. The Thermal Effects on Tissue test showed that the thermally affected zone created by the TempSure™ device was similar to that created by the predicate devices, Surgitron and ForceTriad, in ex-vivo tissue testing. Despite their difference in maximum output power, the devices created a similar TAZ and therefore the devices can be considered substantially equivalent. In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards. The non-clinical testing shows that the device meets design specifications as well as performance requirements.

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Cynosure TempSure K182365

Characteristic	Cynosure TempSure™(KPending)	Cynosure TempSure(K171262)	Ellman Surgitron 4.0Dual RF S5 (PelleveS5) (K123366)	Valley Labs ForceTriad (K051644)
Indications for Use	The 10mm, 15mm, and20mm Smart handpiecesare indicated for non-ablative treatment of mildto moderate facialwrinkles and rhytids	The 10mm, 15mm, and20mm handpieces areindicated for non-ablativetreatment of mild tomoderate facial wrinklesand rhytids	Cutting: Snoring,submucosal palatalshrinkage, traditionaluvulopalatoplasty(RAUP), myringotomywith effect hemorrhagecontrol, epistaxistreatment, turbinateshrinkage, skinincisions biopsy, cysts,abscesses, tumors,cosmetic repairs,development of skinflaps, skin tags, andblepharoplasty	General (includingurologic, thoracic,plastic andreconstructive,arthroscopic),laparoscopic, andgynecologicalprocedures whereelectrosurgical cuttingand coagulation oftissue, and sealing(fusion) of vessels andtissue bundles isperformed, includingsuch procedures asbowel resections,hysterectomies (bothvaginal andabdominal),laparoscopic,cholecystectomies,laparoscopicallyassisted vaginalhysterectomies, gallbladder procedures,Nissen fundoplication,adhesiolysis,oophorectomy, etc.
	The 25mm, and 30mmSmart handpieces provideheating for the purpose ofelevating tissuetemperature for selectedmedical conditions suchas temporary relief ofpain, muscle spasms, andincrease in localcirculation.	The 18mm, 25mm, and30mm handpieces provideheating for the purpose ofelevating tissuetemperature for selectedmedical conditions suchas temporary relief ofpain, muscle spasms, andincrease in localcirculation.	Blended Cutting andCoagulation: Snoring,submucosal palatalshrinkage, traditionaluvulopalatoplasty(RAUP), myringotomywith effectivehemorrhage control,epistaxis treatment,turbinate shrinkage,skin tags, papillomakeloids, keratosis,verrucae, basal cellcarcinoma, nevi,fistulas, epithelidma,cosmetic repairs, cysts,abscesses, and	Vessels (arteries,veins, lymph) 7mmand smaller indiameter, and bundlesas large as will fit in
	The massage device isintended to provide atemporary reduction in theappearance of cellulite	The massage device isintended to provide atemporary reduction in theappearance of cellulite
	The following surgicalmodes are applicable tothe generator:	Coagulation/Hemostasis:Using the surgicalhandpieces andaccessories, generalsurgical proceduresincluding urologic,thoracic, plastic,reconstructive, andgynecological procedureswhere electrosurgical
	Coagulation/Hemostasis:General surgicalprocedures includingurologic, thoracic, plastic,reconstructive, andgynecological procedures
Characteristic	Cynosure TempSure™(KPending)	Cynosure TempSure(K171262)	Ellman Surgitron 4.0Dual RF S5 (Pelleve S5) (K123366)	Valley Labs ForceTriad (K051644)
	where electrosurgicalcoagulation of tissue isperformed	coagulation of tissue isperformed	development of skintags.	the jaws of the devicescan be sealed withLigasure vessel sealing(tissue fusion) output.
	Cutting: snoring.submucosal palatalshrinkage, traditionaluvulopalatoplasty(RAUP), myringotomywith effective hemorrhagecontrol. epistaxistreatment, turbinateshrinkage. skin incisions,biopsy, cysts, abscesses.tumors. cosmetic repairs,development of skinflaps. skin tags andblepharoplasty.		Hemostasis: Control ofbleeding, epilation,telangiectasia.
	Blended Cutting andCoagulation: snoring.submucosal palatalshrinkage, traditionaluvulopalatoplasty(RAUP). myringotomywith effective hemorrhagecontrol. epistaxistreatment, turbinateshrinkage, skin tags,papilloma keloids.keratosis, verrucae, basalcell carcinoma. nevi.fistulas. epithelidma		Fulguration: Basalcell carcinoma,papilloma, cystdestruction, tumors,verrucae, hemostasis.
			Bipolar: Pinpointprecise coagulation,pinpoint hemostasis inany field (wet or dry),snoring, submucosalpalatal shrinkage,traditionaluvulopalatoplasty(RAUP), myringotomywith effectivehemorrhaging control,epistaxis treatment andturbinate shrinkage.
			Wrinkles: Non-ablativetreatment of mild tomoderate facialwrinkles and rhytids.
Characteristic	Cynosure TempSure™(KPending)	Cynosure TempSure(K171262)	Ellman Surgitron 4.0Dual RF S5 (PelleveS5) (K123366)	Valley Labs ForceTriad (K051644)
	cosmetic repairs. cysts.abscesses. anddevelopment of skin flaps.
	Fulguration: basal cellcarcinoma. papilloma.cyst destruction, tumors.verrucae, hemostasis.
	Bipolar: pinpoint precisecoagulation. pinpointhemostasis in any, field(wet or dry). snoring.submucosal palatalshrinkage, traditionaluvulopalatoplasty(RAUP). myringotomywith effective hemorrhagecontrol. epistaxistreatment and turbinateshrinkage
Rx/OTC	Prescription	Prescription	Prescription	Prescription
Energy Type	Radiofrequency	Radiofrequency	Radiofrequency	Radiofrequency
Modality	Monopolar, Bipolar	Monopolar	Monopolar, Bipolar	Monopolar, Bipolar
TemperatureSensing	Temperature-SensitiveHandpiece	Temperature-SensitiveHandpiece	External temperaturemonitor	N/A
TemperatureResponse Time	<1 second	<1 second	N/A	N/A
Handpiece Size	10mm, 15mm, 20mm, 25mm, 30 mm	10mm, 15mm, 18mm,20mm, 25 mm, 30 mm	7.5mm, 10mm, 15mm,20mm	N/A
TreatmentActivation	Fingerswitch, Footswitch	Fingerswitch, Footswitch	Fingerswitch,Footswitch	Fingerswitch,Footswitch
Characteristic	Cynosure TempSure™(KPending)	Cynosure TempSure(K171262)	Ellman Surgitron 4.0Dual RF S5 (PelleveS5) (K123366)	Valley Labs ForceTriad (K051644)
Aesthetic OptimalTemperature	39-45°C	39-45°C	40- 45°C	N/A
Patient ContactingMaterial	Gold-Plated Brass,Polytheramide, Loctite,Delrin	Gold-Plated Brass,Polytheramide, Loctite,Delrin	Gold-Plated Brass	Not applicable -Generator only
Massage Head	Yes	Yes	N/A	N/A
Output Waveform	4.0 MHz Sin-wave CW,Fully Rectified, PartiallyRectified, and 1.7 MHzfor Bipolar	4.0 MHz Sin-wave CW	4.0 MHz Sin-waveCW, Fully Rectified,Partially Rectified,Modulation and 1.7MHz for Bipolar	472 KHz Sin-WaveCW, Fully Rectified,Partially Rectified,
Modes	Surgical (Coag, Cut,Blend, Fulgurate, Bipolar)Smart Handpiece Mode	Surgical Mode (Coagonly), Portrait Mode(Smart Handpiece)	Cut, Blend, Coag,Fulgurate, Bipolar	Cut, Valleylab, Coag,Bipolar, Autobipolar,Ligasure
Max PowerOutput	300W (Surgical)120W (Wrinkles)300W (Tissue Heating)	50W (Surgical - Coagonly)120W (Wrinkles)300W (Tissue Heating)	120W	300W
Dimensions	22.5" x 18" x 12"	18" x 18" x 12"	9.5" x 7.1" x 16.1"	18" x 20" x 10"
Weight	30 lbs	30 lbs	26 lbs	30 lbs

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Cynosure TempSure System K182365

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Cynosure TempSure System K182365

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Cynosure TempSure System K182365

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.