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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:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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