Medical Device Manufacturer · US , Cary , NC

Palomar Medical Products, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1998

Recent clearances: EMERGE FRACTIONAL LASER, MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE, THERMAPULSE

21
Total
21
Cleared
0
Denied

FDA 510(k) Regulatory Record - Palomar Medical Products, Inc. General & Plastic Surgery ✕

19 devices
1-12 of 19
Cleared Nov 14, 2011
EMERGE FRACTIONAL LASER
K111840 · ONG
General & Plastic Surgery · 138d
Cleared Oct 27, 2009
MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
K091446 · ONG
General & Plastic Surgery · 165d
Cleared Jun 01, 2009
LOI SYSTEM
K090525 · ONG
General & Plastic Surgery · 95d
Cleared Feb 27, 2009
ERBIUM FRACTIONAL HANDPIECE
K083900 · GEX
General & Plastic Surgery · 60d
Cleared Feb 13, 2009
PALOMAR ASPIRE LASER PLATFORM
K083165 · GEX
General & Plastic Surgery · 109d
Cleared Jun 20, 2008
PALOMAR LUX 1540 HANDPIECE
K080244 · GEX
General & Plastic Surgery · 141d
Cleared May 29, 2008
PALOMAR ASPIRE LASER PLATFORM
K081416 · GEX
General & Plastic Surgery · 9d
Cleared Apr 16, 2008
PALOMAR ASPIRE LASER PLATFORM
K080567 · GEX
General & Plastic Surgery · 47d
Cleared Mar 26, 2008
MODIFICATION TO PALOMAR LUX1540 HANDPIECE
K073583 · GEX
General & Plastic Surgery · 97d
Cleared Nov 05, 2007
ERBIUM FRACTIONAL HANDPIECE
K071768 · GEX
General & Plastic Surgery · 129d
Cleared May 25, 2007
PALOMAR ERBIUM HANDPIECE
K071152 · GEX
General & Plastic Surgery · 30d
Cleared Feb 27, 2007
PALOMAR LUX1540 HANDPIECE
K061652 · GEX
General & Plastic Surgery · 259d
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