# Viora, Ltd.

- Location (FDA's records): Neanya, IL
- FDA decisions: 11 (2009–2020): 11 510(k) clearances
- Product codes: GEX (4), PBX (4), NUV (1), ONF (1), GEI (1)
- 510(k) review time since 2016: median 87 days, against 134 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 32 (19 its own); citations of its devices by later devices: 28 (19 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
- Syneron Medical, Ltd.: 3 (https://510kreport.com/company/syneron-medical)
- Lpg USA, Inc.: 1 (https://510kreport.com/company/lpg-usa)
- Cutera, Inc.: 1 (https://510kreport.com/company/cutera)
- Chattanooga Group, Inc.: 1 (https://510kreport.com/company/chattanooga-group)
- Mettler Electronics Corp.: 1 (https://510kreport.com/company/mettler-electronics)
- Alma Lasers, Inc.: 1 (https://510kreport.com/company/alma-lasers)
- Sharplight Technologies, Ltd.: 1 (https://510kreport.com/company/sharplight-technologies)
- Radiancy (Israel), Ltd.: 1 (https://510kreport.com/company/radiancy-israel)

## Firms that cite its devices most
- Inmode MD, Ltd.: 2 (https://510kreport.com/company/inmode-md)
- Syneron Candela Corporation: 1 (https://510kreport.com/company/syneron-candela)
- Beijing Honkon Technologies Co., Ltd.: 1 (https://510kreport.com/company/beijing-honkon-technologies)
- Formatk Systems, Ltd.: 1 (https://510kreport.com/company/formatk-systems)
- El Global Trade, Ltd.: 1 (https://510kreport.com/company/el-global-trade)
- Venus Concept, Ltd.: 1 (https://510kreport.com/company/venus-concept)
- Endymed Medical, Ltd.: 1 (https://510kreport.com/company/endymed-medical)
- Bh Group Us, LLC: 1 (https://510kreport.com/company/bh-group-us)

## Its most-cited devices
- K150035: V10 system (2015), cited by 10
- K090221: Reaction System (2009), cited by 7
- K152611: V20 system (2016), cited by 4
- K162363: V30 system, V-Form Handpiece BC Medium applicator (2016), cited by 3
- K142093: V20 System (2014), cited by 2
- K133837: Viora V-Total (2014), cited by 2

## Recent decisions
- K202247: V30 system, V20 system, V10 system, V-VR Hand piece (Dec 9, 2020)
- K201064: V30 System, V20 System, V10 System, V-FR Handpiece (Jul 15, 2020)
- K200468: V30 system, V20 system, V10 system, V-FC Handpiece (May 21, 2020)
- K162363: V30 system, V-Form Handpiece BC Medium applicator (Nov 18, 2016)
- K152611: V20 system (Feb 19, 2016)
- K150035: V10 system (May 1, 2015)
- K142093: V20 System (Nov 14, 2014)
- K141904: Viora V-Touch (Oct 21, 2014)

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