# K171262: TempSure

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Sep 22, 2017 after 144 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 19 generations back to K943450 (1995). 106 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132665: Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - Iec, Ellman International, Inc. (2013) Summary page 4.
- K051644: Valleylab Forcetriad Electrosurgical Generator, Valleylab (2005) Summary page 4.
- K132949: Pellefirm, Ellman International, Inc. (2014) Summary page 4.

## Most influential descendants
- K182365: TempSure System (2018), 15 descendants of its own
- K190678: TempSure (2019), 14 descendants of its own
- K200241: TempSure System (2020), 13 descendants of its own
- K211639: BTL-785W (2022), 7 descendants of its own
- K222556: BTL-785X (2023), 5 descendants of its own

## 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

Source page: https://510kreport.com/device/K171262
Methodology: https://510kreport.com/methodology