Palomar Medical Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 24
What Palomar Medical Technologies, Inc. makes
Palomar Medical Technologies, Inc. manufactures laser and light-based medical devices for aesthetic and dermatological procedures, including handpieces for fractional laser treatments (e.g., LUX1064, LUX1540, LUX1440, LUX2940) and pulsed light systems (e.g., Estelux, Spalight). Their portfolio also includes diode lasers (e.g., LC 100) and Q-switched Nd:YAG laser systems for skin resurfacing, vascular lesion treatment, and hair removal. Additional offerings include aesthetic platforms (e.g., Icon, Primus) and cooling devices (e.g., CoolRoller) designed to complement laser therapies.
The company’s devices are classified under Class II by the FDA, requiring premarket notification (510(k)) clearance before commercial distribution in the United States. These products are listed in the FDA’s 510(k) database, reflecting their regulatory status. The manufacturer operates from the United States, adhering to applicable medical device regulations in that jurisdiction.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Palomar Medical Technologies, Inc. have in the registry?
The registry currently lists 24 devices for Palomar Medical Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Palomar Medical Technologies, Inc.'s devices?
Among its 24 most recently registered devices, Palomar Medical Technologies, Inc. has devices listed in FDA 510(k) (24 devices).
What risk classes do Palomar Medical Technologies, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Palomar Medical Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Palomar Medical Technologies, Inc. in the registry?
The most recently registered devices listed for Palomar Medical Technologies, Inc. include PALOMAR LUX1064 HANDPIECE, PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER, QYAG LASER SYSTEM and PALOMAR ICON (TM) AESTHETIC SYSTEM.