# Novalis Medical, LLC

- Location (FDA's records): Tampa, FL
- FDA decisions: 1 (2004–2004): 1 510(k) clearance
- Product codes: GEX (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 3 (0 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.: 2 (https://510kreport.com/company/palomar-medical-technologies)
- Palomar: 1 (https://510kreport.com/company/palomar)
- Esc Medical Systems, Ltd.: 1 (https://510kreport.com/company/esc-medical-systems)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)
- Radiancy (Israel), Ltd.: 1 (https://510kreport.com/company/radiancy-israel)

## Firms that cite its devices most
- Hair International Systems USA, Inc.: 1 (https://510kreport.com/company/hair-international-systems-usa)
- Aesthera Corporation: 1 (https://510kreport.com/company/aesthera)
- General Project S.R.L.: 1 (https://510kreport.com/company/general-project)

## Its most-cited devices
- K043319: Clareon and Solarus Pulsed Light Devices and Accessories (2004), cited by 3

## Recent decisions
- K043319: Clareon and Solarus Pulsed Light Devices and Accessories (Dec 17, 2004)

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