# K132665: Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - Iec

- Pathway: 510(k) (Traditional)
- Applicant: Ellman International, Inc.
- Decided: Sep 25, 2013 after 29 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: 18 generations back to K943450 (1995). 95 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102698: Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe, Ellman Int'L, Inc. (2011) Summary page 1.

## Most influential descendants
- K171262: TempSure (2017), 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
- K211639: BTL-785W (2022), 7 descendants of its own

## Indications for use
The Pelleve Non-Ablative Wrinkle Treatment System is indicated for the non-ablative treatment of mild to moderate facial wrinkles and rhytids.

Source page: https://510kreport.com/device/K132665
Methodology: https://510kreport.com/methodology