(144 days)
Not Found
No
The document describes a radiofrequency generator with temperature feedback and control, but there is no mention of AI or ML being used for analysis, decision-making, or control of the device's operation.
Yes
The device is indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids, 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, and temporary reduction in the appearance of cellulite. These are all therapeutic actions.
No
The device is described as a radiofrequency generator intended for various treatment procedures, including non-ablative treatment of wrinkles, heating tissue for medical conditions, and hemostasis/coagulation in surgery. While it provides real-time temperature feedback during procedures, this feedback is for monitoring and controlling the treatment, not for diagnosing a medical condition.
No
The device description clearly states it is a radiofrequency generator with various handpieces and accessories, indicating it is a hardware device that utilizes software for control and user interface.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The TempSure Generator is a radiofrequency generator that applies energy directly to the patient's body for various therapeutic and surgical purposes (treating wrinkles, pain relief, muscle spasms, increasing circulation, and surgical coagulation/hemostasis).
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the body.
- Intended Use: The stated intended uses are all related to direct treatment or surgical procedures on the patient.
While the device description mentions "cellular alteration" and the performance studies involve ex-vivo tissue samples for testing thermal effects, the primary function and intended use are not for diagnosing conditions by analyzing samples. The use of Image-J for measuring TAZ is a method used in the testing of the device's effects on tissue, not a diagnostic function of the device itself.
N/A
Intended Use / Indications for Use
The TempSure Generator has the following indications for use: The 10mm, 15mm, and 20mm Portrait handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 18mm, 25mm, and 30mm Portrait 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 Portrait™ massage device is intended to provide a temporary reduction in the appearance of cellulite. Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed.
Product codes (comma separated list FDA assigned to the subject device)
GEI, PBX
Device Description
The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and electrosurgical 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™ system is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids, heating for the purpose of elevating tissue temperature for selected medical conditions, and hemostasis/coagulation for general surgery applications. The generator is used with a temperature sensitive handpiece for aesthetic procedures that provides real-time temperature feedback. This temperature information is displayed on the user interface that shows the temperature set point and actual tissue temperature along with procedure time, system error, and warning codes. A thermistor protrudes at the end of the temperature-sensitive handpiece at the point of patient contact, which provides a constant information feedback loop as to the tissue temperature throughout a procedure.
The TempSure™ System includes: TempSure™ Surgical RF Generator Portrait™ Temperature Sensing Handpieces IEC Power Cord Footswitch Disposable/Reusable Neutral Pad Surgical Fingerswitch/Foot Controlled Handpieces Monopolar Cables Disposable/Reusable Electrodes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Facial (wrinkles and rhytids), general surgical procedures (including urologic, thoracic, plastic, reconstructive, and gynecological procedures), tissue for temporary relief of pain, muscle spasms, and increase in local circulation, and areas with cellulite.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Temperature Monitoring Test: The TempSure with Portrait handpieces was used at three different power settings in various treatment areas on two subjects. The FLIR Thermal Camera was used during the treatment to measure the temperature of the subjects' skin in two minute intervals over the 10 minute total treatment time. The temperature measurements of the Portrait handpieces were compared to those of the FLIR. For each treatment, the average difference in temperature between the FLIR and Portrait handpiece was +/-1.5℃. This +/- 1.5°C margin is equivalent to that of the Fluke Infrared Thermometer, which is used as the external temperature measurement tool for the device's predicates. This test proves that the TempSure with Portrait handpieces has the same temperature measurement capabilities of the Surgitron with GlideSafe or PelleFirm handpieces. In addition, this bench test proved that the TempSure with Portrait handpieces can maintain the desired temperature throughout the treatment and there were no adverse events.
Thermal Effects on Tissue Test: Testing was performed on ex-vivo tissue samples to compare the thermally affected zone (TAZ) of the TempSure and predicate device ForceTriad. Testing was performed using both devices in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings. The depth and lateral TAZ measurements were recorded using Image-J. For each tissue and power setting combination, the TAZ created by the ForceTriad and TempSure were compared. Two of the three power bars for overlapping for each point, which shows that the TAZs were similar. This test shows that the TempSure is substantially equivalent to the ForceTriad device, despite the variation in maximum output power.
Electromagnetic Compatibility and Electrical Safety: Electrical safety testing for the Cynosure TempSure 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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Cynosure dba Ellman Surgitron 4.0 Dual RF S5 - Pelleve (K132665), ValleyLab ForceTriad (K051644), Cynosure dba Ellman PelleFirm (K132949)
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.
Not Found
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
§ 878.4400 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2017
Cynosure, Inc. Amy Tannenbaum Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886
Re: K171262
Trade/Device Name: TempSure Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: September 1, 2017 Received: September 5, 2017
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. The general controls provisions of the Actinclude 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, clear font. The text is black and stands out against a background that appears to have a faded watermark of the letters "FDA". The name is split into two lines, with "Jennifer R." on the first line and "Stevenson -S3" on the second.
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
2
Indications for Use
510(k) Number (if known) K171262
Device Name TempSure
Indications for Use (Describe)
The TempSure Generator has the following indications for use:
The 10mm, 15mm, and 20mm Portrait handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The 18mm, 25mm, and 30mm Portrait 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 Portrait™ massage device is intended to provide a temporary reduction in the appearance of cellulite
Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart C) |
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3
Section 5
510(k) Summary for Cynosure TempSure
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 | May 12, 2017 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | TempSure™ Generator |
| Common or Usual Name | Surgical RF Generator |
| Classification Name | Electrosurgical, Cutting / Coagulation / Accessories |
| Classification Panel | General & Plastic Surgery |
| Regulation | 21 CFR 878.440 |
| Regulatory Class | II |
| Product Code(s) | GEI, PBX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| Predicate Devices | Cynosure dba Ellman Surgitron 4.0 Dual RF S5 - Pelleve |
| (K132665) | |
| ValleyLab ForceTriad (K051644) | |
| Cynosure dba Ellman PelleFirm (K132949) | |
| 807.92(a)(4) Device Description | |
| The Cynosure TempSure™ System is a radiofrequency generator with a | |
| variety of applications both aesthetic and electrosurgical 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™ | |
| system is intended for non-ablative treatment of mild to moderate facial | |
| wrinkles and rhytids, heating for the purpose of elevating tissue | |
| temperature for selected medical conditions, and | |
| hemostasis/coagulation for general surgery applications. The generator | |
| is used with a temperature sensitive handpiece for aesthetic procedures | |
| that provides real-time temperature feedback. This temperature | |
| Section 5 | 510(k) Summary |
| information is displayed on the user interface that shows the temperature set point and actual tissue temperature along with procedure time, system error, and warning codes. A thermistor protrudes at the end of the temperature-sensitive handpiece at the point of patient contact, which provides a constant information feedback loop as to the tissue temperature throughout a procedure. | |
| The TempSure™ System includes: | |
| TempSure™ Surgical RF Generator Portrait™ Temperature Sensing Handpieces IEC Power Cord Footswitch Disposable/Reusable Neutral Pad Surgical Fingerswitch/Foot Controlled Handpieces Monopolar Cables Disposable/Reusable Electrodes | |
| 807.92(a)(5) Intended Use of the Device | |
| The TempSure Generator has the following indications for use: | |
| The 10mm, 15mm, and 20mm Portrait™ handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. | |
| The 18mm, 25mm, and 30mm Portrait™ 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 Portrait™ massage device is intended to provide a temporary reduction in the appearance of cellulite | |
| Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed | |
| 807.92(b)(1) Non-clinical tests submitted | |
| Section 5 | 510(k) Summary |
4
5
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. See Section 18 -Performance Testing, Bench. A brief summary is provided below.
Temperature Monitoring Test
The TempSure with Portrait handpieces was used at three different power settings in various treatment areas on two subjects. The FLIR Thermal Camera was used during the treatment to measure the temperature of the subjects' skin in two minute intervals over the 10 minute total treatment time. The temperature measurements of the Portrait handpieces were compared to those of the FLIR. For each treatment, the average difference in temperature between the FLIR and Portrait handpiece was +/-1.5℃. This +/- 1.5°C margin is equivalent to that of the Fluke Infrared Thermometer, which is used as the external temperature measurement tool for the device's predicates. This test proves that the TempSure with Portrait handpieces has the same temperature measurement capabilities of the Surgitron with GlideSafe or PelleFirm handpieces. In addition, this bench test proved that the TempSure with Portrait handpieces can maintain the desired temperature throughout the treatment and there were no adverse events.
Thermal Effects on Tissue Test
Testing was performed on ex-vivo tissue samples to compare the thermally affected zone (TAZ) of the TempSure and predicate device ForceTriad. Testing was performed using both devices in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings. The depth and lateral TAZ measurements were recorded using Image-J. For each tissue and power setting combination, the TAZ created by the ForceTriad and TempSure were compared. Two of the three power bars for overlapping for each point, which shows that the TAZs were similar. This test shows that the TempSure is substantially equivalent to the ForceTriad device, despite the variation in maximum output power.
Electromagnetic Compatibility and Electrical Safety
Electrical safety testing for the Cynosure TempSure 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". As per the guidance, endoscopic instruments also require compliance with IEC 60601-2-18. The TempSure is not an endoscopic/laparoscopic instrument, and therefore testing to IEC 60601-2-18 is not needed. 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
6
807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted
The nonclinical tests demonstrate that the TempSure™ electrosurgical generator safe and effective and performs as well as or better than the legally marketed predicate devices. The Temperature Monitoring test demonstrated that the temperature sensing feature worked as intended under clinical conditions at multiple temperature settings and handpiece sizes. The device was able to accurately read the temperature of the skin as similar to the Fluke used with the predicate device. It was also able to maintain the desired temperature throughout a treatment with no adverse events. 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 device 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. These non-clinical tests show that the TempSure™ generator can safely deliver RF energy to the patient as intended. The device meets design specifications as well as performance requirements.
7
| Characteristic | Cynosure TempSure™
(K171262) | Ellman Surgitron 4.0
Dual RF S5 (Pelleve S5)
(K132665) | Valley Labs Force
Triad (K051644) | Ellman PelleFirm
(K132949) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The 10mm, 15mm, and
20mm Portrait™
handpieces are indicated
for non-ablative treatment
of mild to moderate facial
wrinkles and rhytids
The 18mm, 25mm, and
30mm Portrait™
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 Portrait™ massage
device is intended to
provide a temporary
reduction in the
appearance of cellulite
Coagulation/Hemostasis:
Using the surgical
handpieces and
accessories, general
surgical procedures
including urologic,
thoracic, plastic. | Cutting: Snoring,
submucosal palatal
shrinkage, traditional
uvulopalatoplasty (RAUP),
myringotomy with effect
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: Snoring,
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 tags. | General (including
urologic, thoracic,
plastic and
reconstructive,
arthroscopic),
laparoscopic, and
gynecological
procedures where
electrosurgical cutting
and coagulation of
tissue, and sealing
(fusion) of vessels and
tissue bundles is
performed, including
such procedures as
bowel resections,
hysterectomies (both
vaginal and abdominal),
laparoscopic,
cholecystectomies,
laparoscopically assisted
vaginal hysterectomies,
gall bladder procedures,
Nissen fundoplication,
adhesiolysis,
oophorecftomy, etc.
Vessels (arteries, veins,
lymph) 7mm and smaller
in diameter, and bundles
as large as will fit in the
jaws of the devices can
be sealed with Ligasure | Tissue Heating: The
PelleFirm RF device is
intended to 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 PelleFirm massage
device is intended to provide
a temporary reduction in the
appearance of cellulite. |
8
| Section 5 |
|---|
510(k) Summary
| Characteristic | Cynosure TempSure™
(K171262) | Ellman Surgitron 4.0
Dual RF S5 (Pelleve S5)
(K132665) | Valley Labs Force
Triad (K051644) | Ellman PelleFirm
(K132949) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | reconstructive, and
gynecological procedures
where electrosurgical
coagulation of tissue is
performed | Hemostasis: Control of
bleeding, epilation,
telangiectasia.
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 hemorrhaging
control, epistaxis treatment
and turbinate shrinkage.
Wrinkles: Non-ablative
treatment of mild to
moderate facial wrinkles
and rhytids. | vessel sealing (tissue
fusion) output. | |
| Rx/OTC | Prescription | Prescription | Prescription | Prescription |
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency | Radiofrequency |
| Modality | Monopolar | Monopolar, Bipolar | Monopolar, Bipolar | Monopolar, Bipolar |
| Characteristic | Cynosure TempSure™
(K171262) | Ellman Surgitron 4.0
Dual RF S5 (Pelleve S5)
(K132665) | Valley Labs Force
Triad (K051644) | Ellman PelleFirm
(K132949) |
| Temperature
Sensing | Temperature-Sensitive
Handpiece | External temperature monitor | N/A | External temperature monitor |
| Temperature
Response Time |