# Sandstone Medical Technologies, LLC

- Location (FDA's records): Birmingham, AL
- FDA decisions: 11 (2004–2012): 11 510(k) clearances
- Product codes: GEX (11)
- Predicates its devices cite: 20 (6 its own); citations of its devices by later devices: 14 (6 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
- Medical Laser Technologies, Ltd.: 3 (https://510kreport.com/company/medical-laser-technologies)
- Continuum Biomedical, Inc.: 2 (https://510kreport.com/company/continuum-biomedical)
- Coherent Star: 1 (https://510kreport.com/company/coherent-star)
- Palomar Medical Technologies, Inc.: 1 (https://510kreport.com/company/palomar-medical-technologies)
- Continuum Electro-Optics, Inc.: 1 (https://510kreport.com/company/continuum-electro-optics)
- Polytec Pi, Inc.: 1 (https://510kreport.com/company/polytec-pi)
- Focus Medical, LLC: 1 (https://510kreport.com/company/focus-medical)
- Radiancy (Israel), Ltd.: 1 (https://510kreport.com/company/radiancy-israel)

## Firms that cite its devices most
- Ultralight Laser Technologies, LLC: 3 (https://510kreport.com/company/ultralight-laser-technologies)
- Palomar Medical Technologies, Inc.: 1 (https://510kreport.com/company/palomar-medical-technologies)
- Global USA Distribution, LLC: 1 (https://510kreport.com/company/global-usa-distribution)
- Cynosure, Inc. Dba Ellman: 1 (https://510kreport.com/company/cynosure-dba-ellman)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd: 1 (https://510kreport.com/company/shanghai-wonderful-opto-electrics-tech)
- Quanta System Spa: 1 (https://510kreport.com/company/quanta-system)

## Its most-cited devices
- K100893: Cheveux Diode Laser System (2010), cited by 3
- K041011: Ultralight II ND:Yag Laser System (2004), cited by 2
- K040563: LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System (25 Watt) (2004), cited by 2
- K110897: Cortex CO2 / ER:Yag Laser System (2011), cited by 1
- K082407: Modification to Ultralight II ND: Yag Laser System (2009), cited by 1
- K110502: Triplex ER. Yag / ND: Yag System (2011), cited by 1

## Recent decisions
- K121162: Polaris Q-Switch Ruby System (Jul 18, 2012)
- K110897: Cortex CO2 / ER:Yag Laser System (Jul 1, 2011)
- K110502: Triplex ER. Yag / ND: Yag System (Apr 27, 2011)
- K110304: Apex ER. Yag / Ipl System (Apr 8, 2011)
- K100893: Cheveux Diode Laser System (Jun 16, 2010)
- K093793: LS-40 CO2 Laser System Model LS-40 (Feb 18, 2010)
- K082407: Modification to Ultralight II ND: Yag Laser System (Feb 3, 2009)
- K082101: LS Family of CO2 Lasers with Scanning Handpiece (Nov 5, 2008)

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