Medical Device Manufacturer · US , Cary , NC

Palomar - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2001

Recent clearances: PALOMAR LUXG HANDPIECE, PALOMAR DERMALUX PULSED LIGHT SYSTEM

2
Total
2
Cleared
0
Denied

Palomar, is a medical device company with a manufacturing facility in Cary, North Carolina. The company specialized in aesthetic and surgical laser systems for dermatological and plastic surgery applications.

Palomar received 2 FDA 510(k) clearances from 2 total submissions, with all devices focused on General & Plastic Surgery. The company's first clearance was granted in 2001, with its latest clearance in 2002. Palomar is currently inactive and should be treated as a historical record, with no FDA submissions or clearances in more than two decades.

The company's cleared devices included pulsed light systems and handpiece technologies designed for surgical and aesthetic procedures. For detailed information on specific device names, product codes, and clearance dates, review the complete 510(k) submission history.

FDA 510(k) Regulatory Record - Palomar

2 devices
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