# K111026: Apollo

- Pathway: 510(k) (Traditional)
- Applicant: Pollogen, Ltd.
- Decided: Nov 16, 2011 after 217 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). 89 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100586: Venus Freeze System, Venus Concept, Ltd. (2010) Summary page 2.
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 2.

## Most influential descendants
- K140255: Stop U (Packed Black Usa); Stop U (Packed White Usa) (2014), 7 descendants of its own
- K182774: STOP U (Packed Black USA), STOP U (Packed White USA) (2019), 5 descendants of its own
- K203665: STOP U Model UXV Device (2021), 4 descendants of its own
- K171359: Pollogen Legend+ System (2017), 4 descendants of its own
- K220322: Pollogen STOP U Model UXV Device (2023), 3 descendants of its own

## Indications for use
The apollo is a non-invasive device intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

Source page: https://510kreport.com/device/K111026
Methodology: https://510kreport.com/methodology