# K102368: Non-Ablative Wrinkle Treatment Handpiece

- Pathway: 510(k) (Special)
- Applicant: Ellman Int'L, Inc.
- Decided: Sep 7, 2010 after 18 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: 16 generations back to K943450 (1995). 93 ancestors in all.
52 later devices descend from it; 2 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101967: Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve', Ellman Int'L, Inc. (2010) Summary page 2.

## Most influential descendants
- K102698: Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe (2011), 39 descendants of its own
- K132665: Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - Iec (2013), 17 descendants of its own
- K132431: Thermage CPT System (2013), 17 descendants of its own
- K171262: TempSure (2017), 16 descendants of its own
- K182365: TempSure System (2018), 15 descendants of its own

## Indications for use
Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV

Source page: https://510kreport.com/device/K102368
Methodology: https://510kreport.com/methodology