# Spectragenics, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 5 (2003–2009): 5 510(k) clearances
- Product codes: GEX (5)
- Predicates its devices cite: 39 (4 its own); citations of its devices by later devices: 14 (4 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
- Palomar Medical Technologies, Inc.: 8 (https://510kreport.com/company/palomar-medical-technologies)
- Star Medical Technologies, Inc.: 7 (https://510kreport.com/company/star-medical-technologies)
- Radiancy (Israel), Ltd.: 4 (https://510kreport.com/company/radiancy-israel)
- Coherent Star: 3 (https://510kreport.com/company/coherent-star)
- Iridex Corp: 3 (https://510kreport.com/company/iridex)
- Opus Medical, Inc.: 3 (https://510kreport.com/company/opus-medical)
- Curelight, Ltd.: 2 (https://510kreport.com/company/curelight)
- Palomar Medical Products, Inc.: 2 (https://510kreport.com/company/palomar-medical-products)

## Firms that cite its devices most
- Tria Beauty, Inc.: 2 (https://510kreport.com/company/tria-beauty)
- Home Skinovations, Ltd.: 2 (https://510kreport.com/company/home-skinovations)
- Epilady 2000, LLC: 1 (https://510kreport.com/company/epilady-2000)
- Syneron Beauty, Ltd.: 1 (https://510kreport.com/company/syneron-beauty)
- Palomar Medical Technologies, Inc.: 1 (https://510kreport.com/company/palomar-medical-technologies)
- Shaser, Inc.: 1 (https://510kreport.com/company/shaser)
- Syneron Medical, Ltd.: 1 (https://510kreport.com/company/syneron-medical)
- Wuhan Lotuxs Technology Co., Ltd.: 1 (https://510kreport.com/company/wuhan-lotuxs-technology)

## Its most-cited devices
- K090820: Tria Hair Removal Laser System (2009), cited by 7
- K052848: Spectra Hair Removal Laser (2005), cited by 2
- K053527: Spectra Hair Removal Laser (2008), cited by 2
- K032846: Spectra Pulsed Diode Laser, Model DR-1 (2003), cited by 2
- K060567: Spectragenics Ats-1 (2006), cited by 1

## Recent decisions
- K090820: Tria Hair Removal Laser System (Dec 23, 2009)
- K053527: Spectra Hair Removal Laser (Feb 1, 2008)
- K060567: Spectragenics Ats-1 (Apr 28, 2006)
- K052848: Spectra Hair Removal Laser (Dec 27, 2005)
- K032846: Spectra Pulsed Diode Laser, Model DR-1 (Dec 11, 2003)

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