# K200241: TempSure System

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, LLC
- Decided: Mar 25, 2020 after 54 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 110 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190678: TempSure, Cynosure, Inc. (2019) Summary page 5.

## Most influential descendants
- K211639: BTL-785W (2022), 7 descendants of its own
- K222556: BTL-785X (2023), 5 descendants of its own
- K233604: BTL-785S (2024), 3 descendants of its own
- K242532: BTL-785BNF-E (2024), 1 descendant of its own
- K212891: TempSure System (2022), 1 descendant of its own

## Indications for use
The TempSure™ System has the following indications for use: The 10mm, 15mm, and 20mm Smart Handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 18mm, 25mm, 30mm, 60mm Smart Handpieces and 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

Source page: https://510kreport.com/device/K200241
Methodology: https://510kreport.com/methodology