# Pollogen, Ltd.

- Location (FDA's records): Tel Aviv, IL
- FDA decisions: 18 (2011–2025): 18 510(k) clearances
- Product codes: GEI (11), PAY (5), NGX (1), PBX (1)
- 510(k) review time since 2016: median 127 days, against 125 for FDA's reviews in the same codes and years (6 of 11 faster)
- Predicates its devices cite: 20 (12 its own); citations of its devices by later devices: 19 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- A-1 Engineering: 1 (https://510kreport.com/company/a-1-engineering)
- Invasix, Ltd.: 1 (https://510kreport.com/company/invasix)
- El Global Trade, Ltd.: 1 (https://510kreport.com/company/el-global-trade)
- Syneron Medical, Ltd.: 1 (https://510kreport.com/company/syneron-medical)
- Venus Concept, Ltd.: 1 (https://510kreport.com/company/venus-concept)
- Endymion Medical, Ltd.: 1 (https://510kreport.com/company/endymion-medical)
- Endymed Medical, Ltd.: 1 (https://510kreport.com/company/endymed-medical)
- InMode, Ltd.: 1 (https://510kreport.com/company/inmode)

## Firms that cite its devices most
- El Global Trade, Ltd.: 2 (https://510kreport.com/company/el-global-trade)
- El.En S.P.A.: 2 (https://510kreport.com/company/el-en)
- Sharplight Technologies, Ltd.: 1 (https://510kreport.com/company/sharplight-technologies)
- Alic Iotech, LLC: 1 (https://510kreport.com/company/alic-iotech)
- Lumenis Be, Ltd.: 1 (https://510kreport.com/company/lumenis-be)

## Its most-cited devices
- K232903: Legend X Platform (2023), cited by 3
- K111026: Apollo (2011), cited by 3
- K220322: Pollogen STOP U Model UXV Device (2023), cited by 3
- K140255: Stop U (Packed Black Usa); Stop U (Packed White Usa) (2014), cited by 2
- K173503: Pollogen Legend System (2018), cited by 2
- K203665: STOP U Model UXV Device (2021), cited by 1

## Recent decisions
- K242227: Geneo X Elite (Oct 12, 2025)
- K252576: Legend X Platform (Sep 12, 2025)
- K250734: OptiLUV Device (Sep 10, 2025)
- K243217: Legend X Desktop System (Nov 1, 2024)
- K240999: Legend X Applicator VO (May 8, 2024)
- K233766: Geneo X Elite (May 7, 2024)
- K232903: Legend X Platform (Oct 17, 2023)
- K220322: Pollogen STOP U Model UXV Device (May 4, 2023)

Source page: https://510kreport.com/company/pollogen