TempSure System
Device Facts
| Record ID | K212891 |
|---|---|
| Device Name | TempSure System |
| Applicant | Cynosure, LLC |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Mar 18, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Small 10mm, 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The Small 10mm, 18mm, 25mm, 30mm, and 60mm handpieces and the FlexSure Applicators 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: 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 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 Story
TempSure System is a radiofrequency (RF) generator for aesthetic and surgical procedures. Inputs include user settings via GUI and activation via foot/hand-switch. Device delivers RF energy to tissue to induce heating or surgical cutting/coagulation. Used in clinical settings by healthcare professionals. New Small 10mm handpiece includes an integrated accelerometer to detect motion; RF output disables if no motion is detected to prevent overheating. Output allows clinicians to perform precise tissue heating or surgical interventions. Benefits include wrinkle reduction, pain relief, and surgical hemostasis.
Clinical Evidence
Bench testing only. Tissue heating bench test confirmed the Small 10mm handpiece maintains target temperature for 10 minutes under simulated clinical conditions. Electrical safety and electromagnetic compatibility testing performed per IEC 60601-1, 60601-1-2, and 60601-2-2.
Technological Characteristics
RF generator; 4.0 MHz (monopolar) and 1.7 MHz (bipolar) output. Materials: Gold-plated 316 stainless steel (Small 10mm handpiece), PVDF, gold-plated brass/aluminum, Polyetherimide (Ultem 1000), Polyimide, Hydrogel, Polycarbonate (Lexan HP-1), Delrin. Features integrated accelerometer for motion detection. Connectivity: Standalone. Sterilization: Not specified.
Indications for Use
Indicated for patients requiring non-ablative treatment of mild to moderate facial wrinkles/rhytids, temporary relief of pain, muscle spasms, increased local circulation, temporary reduction in cellulite appearance, and various general surgical procedures (coagulation, cutting, hemostasis).
Regulatory Classification
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.
Predicate Devices
- Cynosure TempSure (K200241)
Submission Summary (Full Text)
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March 18, 2022
Cynosure, LLC Michael King Regulatory Affairs Specialist III 5 Carlisle Road Westford, Massachusetts 01886
Re: K212891
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, PBX Dated: February 17, 2022 Received: February 18, 2022
Dear Michael King:
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/cfpmn/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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) BBCDOX K212891
Device Name TempSure System
#### Indications for Use (Describe)
The Small 10mm, 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The Small 10mm, 18mm, 25mm, 30mm, and 60mm handpieces and the FlexSure Applicators 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, turnors, 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 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.
| Type of Use ( <i>Select one or both, as applicable</i> ) |
|------------------------------------------------------------------------------------------------|
| <span style="padding-left: 20px;"><b>☑</b> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
| <span style="padding-left: 20px;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Cynosure, LLC
Section 5
510(k) Summary
### 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, LLC |
| Address | 5 Carlisle Road, Westford MA, 01886 |
| Phone Number | 781-993-2454 |
| Fax Number | 978-256-6556 |
| Establishment Registration<br>Number | 1222993 |
| Contact Person | Michael King |
| Preparation Date | September 9, 2021 |
| 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;<br>Massager, Vacuum, Radio Frequency Induced Heat |
| Classification Panel | General & Plastic Surgery |
| Regulation | 21 CFR 878.4440 |
| 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 (K200241) |
| 807.92(a)(4) Device Description | |
| | The Cynosure TempSure™ System is a radiofrequency generator with<br>a variety of applications both aesthetic and surgical procedures. The<br>intended action is achieved through application of radiofrequency<br>energy to the patient which results in minimization of heat dissipation<br>and cellular alteration. Output of energy is controlled via the guided<br>user interface (GUI) and the foot and/or hand-switch.<br><br>An additional Small 10mm Smart Handpiece is now included for the<br>purpose of tissue heating for selected medical conditions and the<br>treatment of mild to moderate facial wrinkles and rhytids. The<br>handpiece is capable of operating at maximum energy setting of 30<br>(28W) in the Smart Handpiece Mode. There have been no additional<br>changes to the previous existing handpieces (10, 15, 18, 20, 25, 30 or<br>60mm), FlexSure Applicators, or Surgical modes (COAG, Cut, Blend, |
| Section 5 | 510(k) Summary |
| | Bipolar, Fulgurate) of the system. The TempSure system is still used with the same existing electrosurgical accessories. |
| | The TempSure™ System includes: |
| | TempSure™ Generator Temperature Sensing Handpieces (Small 10, 10, 15, 18, 20, 25, 30, and 60mm) Massage Heads (25, 30, and 60mm) FlexSure™ Applicators (Large and Medium) IEC Power Cord Footswitch Disposable/Reusable Neutral Pads Surgical Fingerswitch/Foot Controlled Handpieces Monopolar Cables Disposable/Reusable Electrodes, Forceps |
| | 807.92(a)(5) Intended Use of the Device |
| | The Small 10mm, 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.<br><br>The Small 10mm, 18mm, 25mm, 30mm, and 60mm handpieces and the FlexSure Applicators 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.<br><br>The massage device is intended to provide a temporary reduction in the appearance of cellulite<br><br>The following surgical modes are applicable to the generator:<br><br>Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed.<br><br>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.<br><br>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<br>development of skin flaps. |
| | <b>Fulguration:</b> basal cell carcinoma, papilloma, cyst destruction,<br>tumors, verrucae, hemostasis. |
| | <b>Bipolar:</b> pinpoint precise coagulation, pinpoint hemostasis in any,<br>field (wet or dry), snoring, submucosal palatal shrinkage, traditional<br>uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage<br>control, epistaxis treatment, and turbinate shrinkage |
| | 807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to |
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Section 5
the Predicate - Please refer to the System Specification Comparison Table below
### 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.
#### Tissue Heating with Small 10mm Handpiece
Bench testing was conducted to show that the new Small 10mm Smart Handpiece, when used in a simulated clinical condition, was able to heat and maintain temperature of the treatment area for 10 minutes. Refer to Section 18 - Performance Testing, Bench for additional information.
### 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 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 o 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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Page 4 of 7 Cynosure, LLC
Section 5
510(k) Summary
The non-clinical tests demonstrate that the TempSure generator with the Small 10mm handpiece is safe and effective and performs as well or better than the legally marketed predicate device. The Tissue Heating bench test demonstrated that the device is able to maintain temperature for at least the 10minute treatment time when used as intended under clinical conditions at various treatment areas and settings. In addition, the Electrosurgical 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 using the Small 10mm handpiece meets design specifications as well as performance requirements.
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Cynosure TempSure 510(k)
KPending
| Characteristic | Cynosure TempSure System (KPending) | Cynosure TempSure System (K200241) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Small 10mm, 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.<br><br>The Small 10mm, 18mm, 25mm, 30mm, and 60mm handpieces and the FlexSure Applicators 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 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.<br><br>The 18mm, 25mm, 30mm, and 60mm handpieces and the FlexSure Applicators 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 massage device is intended to provide a temporary reduction in the appearance of cellulite |
| | The following surgical modes are applicable to the generator: | 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 | 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. | 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: snoring. submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP). myringotomy with effective hemorrhage control. epistaxis treatment, | Blended Cutting and Coagulation: snoring. submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP). myringotomy with effective hemorrhage control. epistaxis treatment, |
| Section 5 | 510(k) Summary | |
| Characteristic | Cynosure TempSure System (KPending) | Cynosure TempSure System (K200241) |
| | effective hemorrhage control. epistaxis treatment,<br>turbinate shrinkage, skin tags, papilloma keloids.<br>keratosis, verrucae, basal cell carcinoma. nevi. fistulas.<br>epithelidma. cosmetic repairs. cysts. abscesses. and<br>development of skin flaps. | turbinate shrinkage, skin tags, papilloma keloids.<br>keratosis, verrucae, basal cell carcinoma. nevi. fistulas.<br>epithelidma. cosmetic repairs. cysts. abscesses. and<br>development of skin flaps. |
| | Fulguration: basal cell carcinoma. papilloma. cyst<br>destruction, tumors. verrucae, hemostasis. | Fulguration: basal cell carcinoma. papilloma. cyst<br>destruction, tumors. verrucae, hemostasis. |
| | Bipolar: pinpoint precise coagulation. pinpoint<br>hemostasis in any, field (wet or dry). snoring.<br>submucosal palatal shrinkage, traditional<br>uvulopalatoplasty (RAUP). myringotomy with<br>effective hemorrhage control. epistaxis treatment and<br>turbinate shrinkage | Bipolar: pinpoint precise coagulation. pinpoint<br>hemostasis in any, field (wet or dry). snoring.<br>submucosal palatal shrinkage, traditional<br>uvulopalatoplasty (RAUP). myringotomy with<br>effective hemorrhage control. epistaxis treatment and<br>turbinate shrinkage |
| Rx/OTC | Prescription | Prescription |
| Energy Type | Radiofrequency | Radiofrequency |
| Modality | Monopolar, Bipolar | Monopolar, Bipolar |
| Temperature Sensing | Temperature-Sensitive Handpiece | Temperature-Sensitive Handpiece |
| Temperature Response Time | <1 second | <1 second |
| Handpiece Size | Small 10mm, 10mm, 15mm, 18mm, 20mm, 25 mm, 30<br>mm, 60mm, Large & Medium FlexSure Applicators | 10mm, 15mm, 18mm, 20mm, 25 mm, 30 mm, 60mm,<br>Large & Medium FlexSure Applicators |
| Massage Head | Yes (25mm, 30mm, 60mm) | Yes (25mm, 30mm, 60mm) |
| Surgical Accessories | The TempSure™ generator is compatible with<br>existing, previously cleared electrosurgical<br>accessories: neutral pads, electrodes, surgical<br>handpieces, cables, etc. | The TempSure™ generator is compatible with<br>existing, previously cleared electrosurgical accessories:<br>neutral pads, electrodes, surgical handpieces, cables,<br>etc. |
| Treatment Activation | Fingerswitch Footswitch | Fingerswitch Footswitch |
| Section 5 | | 510(k) Summary |
| Characteristic | Cynosure TempSure System (KPending) | Cynosure TempSure System (K200241) |
| esthetic Optimal<br>Temperature | 39-45°C | 39-45°C |
| Patient Contacting Material | Small 10mm Handpiece: Gold-plated 316 stainless<br>steel<br>Handpieces: PVDF coating, Gold-plated brass, Gold-<br>plated aluminum, Loctite (M-31CL), Polyetherimide<br>(Ultem 1000)<br>FlexSure: Polyimide, Hydrogel<br>Massage Heads: Polycarbonate (Sabic Lexan HP-1),<br>Delrin | Handpieces: PVDF coating, Gold-plated brass, Gold-<br>plated aluminum, Loctite (M-31CL), Polyetherimide<br>(Ultem 1000)<br>FlexSure: Polyimide, Hydrogel<br>Massage Heads: Polycarbonate (Sabic Lexan HP-1),<br>Delrin |
| Input Voltage | 110V | 110V |
| Output Waveform | 4.0 MHz Sin-wave CW, Fully Rectified, Partially<br>Rectified, and 1.7 MHz for Bipolar | 4.0 MHz Sin-wave CW, Fully Rectified, Partially<br>Rectified, and 1.7 MHz for Bipolar |
| Modes | Surgical (Coag, Cut, Blend, Fulgurate, Bipolar)<br>Smart Handpiece Mode…
