(28 days)
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, 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, epithelioma, 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.
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.
There have been no changes to the TempSure Device or handpieces (Small 10, 10, 15, 18, 20, 25, 30 or 60mm), FlexSure Applicators, or Surgical modes (COAG, Cut, Blend, 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
The provided document (K223292) is a 510(k) premarket notification for the Cynosure TempSure System. This type of submission asserts substantial equivalence to a legally marketed predicate device, rather than providing new clinical data to establish safety and effectiveness from scratch. As such, the document explicitly states:
- "807.92(b)(1) Non-clinical tests submitted– N/A – No non-clinical tests submitted"
- "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– N/A"
Therefore, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, because no new non-clinical or clinical studies were submitted for this 510(k) notification.
The submission establishes substantial equivalence by demonstrating that the device has the same intended use and similar technological characteristics as its predicate device (Cynosure TempSure System, K212891), with no changes to the device or handpieces, only an update to labeling with an additional contraindication.
Because no studies were submitted, the following requested information cannot be extracted from this document:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 23, 2022
Cynosure LLC Michael King Sr. Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886
Re: K223292
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: October 25, 2022 Received: October 26, 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 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
{1}------------------------------------------------
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 mediation-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).
Sincerelv.
Jessica Carr -S
for 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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223292
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, 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, epithelioma, 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 (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.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Section 6 – 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 Number | 1222993 |
| Contact Person | Michael King |
| Preparation Date | October 24, 2022 |
| 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; 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 | TempSure System (K212891) |
| 807.92(a)(4) 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.There have been no changes to the TempSure Device or handpieces (Small 10, 10, 15, 18, 20, 25, 30 or 60mm), FlexSure Applicators, or Surgical modes (COAG, Cut, Blend, 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. | |
| 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, epithelioma, 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. | |
| 807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the Predicate | |
| There have been no changes to the technological characteristics of the device compared to the predicate TempSure System (K212891). Device labeling has been updated to include an additional contraindication for patients with medical conditions that have decreased function of the peripheral nervous tissue. | |
| 807.92(b)(1) Non-clinical tests submitted– N/A – No non-clinical tests submitted | |
| 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– N/A |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
System Specifications
| Characteristic | Cynosure TempSure System (KPending) | Cynosure TempSure System (K212891) |
|---|---|---|
| Indications for Use | The Small 10mm, 10mm, 15mm, and 20mm handpieces areindicated for non-ablative treatment of mild to moderatefacial wrinkles and rhytids. | The Small 10mm, 10mm, 15mm, and 20mm handpieces areindicated for non-ablative treatment of mild to moderatefacial wrinkles and rhytids. |
| The Small 10mm, 18mm, 25mm, 30mm, and 60mmhandpieces and the FlexSure Applicators provide heatingfor the purpose of elevating tissue temperature for selectedmedical conditions such as temporary relief of pain, musclespasms, and increase in local circulation. | The Small 10mm, 18mm, 25mm, 30mm, and 60mmhandpieces and the FlexSure Applicators provide heatingfor the purpose of elevating tissue temperature for selectedmedical conditions such as temporary relief of pain, musclespasms, and increase in local circulation. | |
| The massage device is intended to provide a temporaryreduction in the appearance of cellulite | The massage device is intended to provide a temporaryreduction in the appearance of cellulite | |
| The following surgical modes are applicable to thegenerator: | The following surgical modes are applicable to thegenerator: | |
| Coagulation/Hemostasis: General surgical proceduresincluding urologic, thoracic, plastic, reconstructive, andgynecological procedures where electrosurgical coagulationof tissue is performed. | Coagulation/Hemostasis: General surgical proceduresincluding urologic, thoracic, plastic, reconstructive, andgynecological procedures where electrosurgical coagulationof tissue is performed. | |
| Cutting: snoring, submucosal palatal shrinkage, traditionaluvulopalatoplasty (RAUP), myringotomy with effectivehemorrhage control, epistaxis treatment, turbinateshrinkage, skin incisions, biopsy, cysts, abscesses, tumors,cosmetic repairs, development of skin flaps, skin tags andblepharoplasty. | Cutting: snoring, submucosal palatal shrinkage, traditionaluvulopalatoplasty (RAUP), myringotomy with effectivehemorrhage control, epistaxis treatment, turbinateshrinkage, skin incisions, biopsy, cysts, abscesses, tumors,cosmetic repairs, development of skin flaps, skin tags andblepharoplasty. | |
| Blended Cutting and Coagulation: snoring, submucosalpalatal shrinkage, traditional uvulopalatoplasty (RAUP),myringotomy with effective hemorrhage control, epistaxistreatment, turbinate shrinkage, skin tags, papilloma keloids,keratosis, verrucae, basal cell carcinoma, nevi, fistulas, | Blended Cutting and Coagulation: snoring, submucosalpalatal shrinkage, traditional uvulopalatoplasty (RAUP),myringotomy with effective hemorrhage control, epistaxistreatment, turbinate shrinkage, skin tags, papilloma keloids,keratosis, verrucae, basal cell carcinoma, nevi, fistulas, | |
| Characteristic | Cynosure TempSure System (KPending) | Cynosure TempSure System (K212891) |
| epithelioma, cosmetic repairs, cysts, abscesses, anddevelopment of skin flaps. | epithelioma, cosmetic repairs, cysts, abscesses, anddevelopment of skin flaps. | |
| Fulguration: basal cell carcinoma, papilloma, cystdestruction, tumors, verrucae, hemostasis. | Fulguration: basal cell carcinoma, papilloma, cystdestruction, tumors, verrucae, hemostasis. | |
| Bipolar: pinpoint precise coagulation, pinpoint hemostasisin any field (wet or dry), snoring, submucosal palatalshrinkage, traditional uvulopalatoplasty (RAUP),myringotomy with effective hemorrhage control, epistaxistreatment, and turbinate shrinkage. | Bipolar: pinpoint precise coagulation, pinpoint hemostasisin any field (wet or dry), snoring, submucosal palatalshrinkage, traditional uvulopalatoplasty (RAUP),myringotomy with effective hemorrhage control, epistaxistreatment, and 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 mm,60mm, Large & Medium FlexSure Applicators | Small 10mm, 10mm, 15mm, 18mm, 20mm, 25 mm, 30 mm,60mm, Large & Medium FlexSure Applicators |
| Massage Head | Yes (25mm, 30mm, 60mm) | Yes (25mm, 30mm, 60mm) |
| Surgical Accessories | The TempSure™ generator is compatible with existing,previously cleared electrosurgical accessories: neutral pads,electrodes, surgical handpieces, cables, etc. | The TempSure™ generator is compatible with existing,previously cleared electrosurgical accessories: neutral pads,electrodes, surgical handpieces, cables, etc. |
| Treatment Activation | Fingerswitch, Footswitch | Fingerswitch, Footswitch |
| Aesthetic OptimalTemperature | 39-45°C | 39-45°C |
| Patient Contacting Material | Small 10mm Handpiece: Gold-plated 316 stainless steelHandpieces: PVDF coating, Gold-plated brass, Gold-platedaluminum, Loctite (M-31CL), Polyetherimide (Ultem 1000)FlexSure: Polyimide, HydrogelMassage Heads: Polycarbonate (Sabic Lexan HP-1), Delrin | Small 10mm Handpiece: Gold-plated 316 stainless steelHandpieces: PVDF coating, Gold-plated brass, Gold-platedaluminum, Loctite (M-31CL), Polyetherimide (Ultem 1000)FlexSure: Polyimide, HydrogelMassage Heads: Polycarbonate (Sabic Lexan HP-1), Delrin |
| Input Voltage | 110V | 110V |
| Output Waveform | 4.0 MHz Sin-wave CW, Fully Rectified, Partially Rectifiedand 1.7 MHz for Bipolar | 4.0 MHz Sin-wave CW, Fully Rectified, Partially Rectified.and 1.7 MHz for Bipolar |
| Characteristic | Cynosure TempSure System (KPending) | Cynosure TempSure System (K212891) |
| Modes | Surgical (Coag, Cut, Blend, Fulgurate, Bipolar) | Surgical (Coag, Cut, Blend, Fulgurate, Bipolar) |
| Smart Handpiece Mode | Smart Handpiece Mode | |
| Max Power Output | 300W (Surgical) | 300W (Surgical) |
| 120W (Wrinkles) | 120W (Wrinkles) | |
| 300W (Tissue Heating) | 300W (Tissue Heating) | |
| Safety Features | • Compliant with medical electrical equipmentrequirements for safety and performance (60601-1,60601-1-2, 60601-2-2)• Small 10mm Smart Handpiece is equipped with anintegrated accelerometer to detect handpiece motion. RFwill be disabled when no handpiece motion is detected. | • Compliant with medical electrical equipmentrequirements for safety and performance (60601-1,60601-1-2, 60601-2-2)• Small 10mm Smart Handpiece is equipped with anintegrated accelerometer to detect handpiece motion. RFwill be disabled when no handpiece motion is detected. |
| Crest Factor | 3.1 (Surgical) | 3.1 (Surgical) |
| 1.5 (Smart Handpiece) | 1.5 (Smart Handpiece) | |
| Dimensions | 22.5" x 18" x 12" | 22.5" x 18" x 12" |
| Weight | 30 lbs | 30 lbs |
{8}------------------------------------------------
{9}------------------------------------------------
§ 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.