# Quantel Medical

- Location (FDA's records): Hot Springs, AR
- FDA decisions: 33 (2000–2026): 33 510(k) clearances
- Names in FDA's records: Quantel Medical (30); Quantel Medical S.A. (2); Quantel Medical, Inc. (1)
- Product codes: HQF (13), IYO (10), GEX (9), FTC (1)
- 510(k) review time since 2016: median 93 days, against 75 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 75 (18 its own); citations of its devices by later devices: 35 (18 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
- Laserscope: 5 (https://510kreport.com/company/laserscope)
- Iridex Corp: 5 (https://510kreport.com/company/iridex)
- Lumenis, Inc.: 4 (https://510kreport.com/company/lumenis)
- Candela Corp.: 3 (https://510kreport.com/company/candela)
- Nidek, Inc.: 3 (https://510kreport.com/company/nidek)
- Cosmos Medical Technology: 3 (https://510kreport.com/company/cosmos-medical-technology)
- Altus Medical, Inc.: 2 (https://510kreport.com/company/altus-medical)
- B.V. Intl. S.A.: 2 (https://510kreport.com/company/intl)

## Firms that cite its devices most
- Quantel S.A.: 2 (https://510kreport.com/company/quantel)
- Lightmed Corp.: 2 (https://510kreport.com/company/lightmed)
- BTL Industries, Inc.: 2 (https://510kreport.com/company/btl-industries)
- Reliant Technologies, Inc.: 1 (https://510kreport.com/company/reliant-technologies)
- Portable Ophthalmic Devices, Inc.: 1 (https://510kreport.com/company/portable-ophthalmic-devices)
- Topcon Medical Laser Systems, Inc.: 1 (https://510kreport.com/company/topcon-medical-laser-systems)
- Dgh Technology, Inc.: 1 (https://510kreport.com/company/dgh-technology)
- Asclepion-Meditec AG: 1 (https://510kreport.com/company/asclepion-meditec)

## Its most-cited devices
- K993674: Pocket Ultrasonic Pachymeter (2000), cited by 4
- K100678: Supra Scan Delivery System (2010), cited by 3
- K020071: Viridis Derma Laser (2002), cited by 3
- K051851: Aviso Ophthalmic Ultrasound System (2005), cited by 3
- K023464: Viridis Twin Ophthalmic Photocoagulator (2003), cited by 2
- K043236: Frequency Doubled ND: Yag Photocoagulator, Model Vitra (2005), cited by 2

## Recent decisions
- K251507: Integre Lio (Feb 6, 2026)
- K232302: Pocket III (Apr 26, 2024)
- K220430: Capsulo (May 12, 2022)
- K213254: Axialis Ophthalmic Ultrasound System (Nov 15, 2021)
- K201502: Vitra 810 (Aug 6, 2020)
- K191962: Vitra 2 (Dec 5, 2019)
- K183414: Absolu (Mar 20, 2019)
- K180265: COMPACT TOUCH Ophthalmic Ultrasound System (Mar 2, 2018)

Source page: https://510kreport.com/company/quantel-medical