# K132949: Pellefirm

- Pathway: 510(k) (Traditional)
- Applicant: Ellman International, Inc.
- Decided: Feb 20, 2014 after 154 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: 1 generation back to K122389 (2012). 1 ancestor in all.
48 later devices descend from it; 4 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122389: Trusculpt, Cutera, Inc. (2012) Summary page 1.

## Most influential descendants
- K171262: TempSure (2017), 16 descendants of its own
- K143040: Exilis XP (2015), 16 descendants of its own
- 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

## Indications for use
The PelleFirm RF device is intended to 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 PelleFirm massage device is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K132949
Methodology: https://510kreport.com/methodology