# Lutronic Corporation

- Location (FDA's records): North Reading, MA
- FDA decisions: 29 (2007–2025): 29 510(k) clearances
- Product codes: GEX (20), GEI (3), ONG (2), NGX (1), HQF (1), PDZ (1), ILY (1)
- 510(k) review time since 2016: median 190 days, against 97 for FDA's reviews in the same codes and years (4 of 11 faster)
- Predicates its devices cite: 54 (13 its own); citations of its devices by later devices: 59 (13 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lumenis, Inc.: 7 (https://510kreport.com/company/lumenis)
- Reliant Technologies, Inc.: 5 (https://510kreport.com/company/reliant-technologies)
- Cynosure, Inc.: 4 (https://510kreport.com/company/cynosure)
- Cutera, Inc.: 3 (https://510kreport.com/company/cutera)
- Sharplan Lasers, Inc.: 3 (https://510kreport.com/company/sharplan-lasers)
- Quanta System Spa: 2 (https://510kreport.com/company/quanta-system)
- Fotona D.D.: 2 (https://510kreport.com/company/fotona-dd)
- Solta Medical, Inc.: 2 (https://510kreport.com/company/solta-medical)

## Firms that cite its devices most
- Shanghai Apolo Medical Technology Co., Ltd.: 3 (https://510kreport.com/company/shanghai-apolo-medical-technology)
- Wontech Co., Ltd.: 3 (https://510kreport.com/company/wontech)
- VIOL Co., Ltd.: 2 (https://510kreport.com/company/viol)
- Candela Corp.: 2 (https://510kreport.com/company/candela)
- Quanta System Spa: 2 (https://510kreport.com/company/quanta-system)
- Bio-Med USA, Inc.: 2 (https://510kreport.com/company/bio-med-usa)
- Bison Medical Co, Ltd.: 2 (https://510kreport.com/company/bison-medical)
- Fotona D.O.O.: 1 (https://510kreport.com/company/fotona-doo)

## Its most-cited devices
- K113588: Spectra Laser System (2012), cited by 9
- K121481: Infini Radiofrequency System (2013), cited by 9
- K213569: HOLLYWOOD SPECTRA Laser System (2022), cited by 5
- K080496: Mosaic ECO2 Laser System (2008), cited by 4
- K171009: LASEMD Laser System (2017), cited by 4
- K130199: Clarity LPC Laser System (2013), cited by 3

## Recent decisions
- K251327: XERF (Aug 11, 2025)
- K244060: eCO2 3D (Jul 31, 2025)
- K213748: CoreLevee (Oct 14, 2022)
- K213569: HOLLYWOOD SPECTRA Laser System (Feb 4, 2022)
- K203788: DermaV Laser System (Mar 26, 2021)
- K183566: CLARITY II Laser System (Jun 14, 2019)
- K180945: LUTRONIC GENIUS Radiofrequency System (Dec 10, 2018)
- K173700: PICOPLUS Laser System (Jun 19, 2018)

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