510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Palomar Medical Products, Inc.

Cary, NC, US

Palomar Medical Products, Inc. appears in FDA device records in Cary, NC. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 21 510(k) clearances for Palomar Medical Products, Inc. between 1998 and 2011. The busiest year on record is 2009, with 5. The most recent is 2011, with 1.

Clearances by year, as a table
510(k) clearance decisions for Palomar Medical Products, Inc., by decision year
YearClearances
19983
19991
20011
20031
20041
20051
20073
20084
20095
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K111840EMERGE FRACTIONAL LASERONGSubstantially Equivalent
K091446MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECEONGSubstantially Equivalent
K092222THERMAPULSEILYSubstantially Equivalent
K090525LOI SYSTEMONGSubstantially Equivalent
K083900ERBIUM FRACTIONAL HANDPIECEGEXSubstantially Equivalent
K083165PALOMAR ASPIRE LASER PLATFORMGEXSubstantially Equivalent
K080244PALOMAR LUX 1540 HANDPIECEGEXSubstantially Equivalent
K081416PALOMAR ASPIRE LASER PLATFORMGEXSubstantially Equivalent
K080567PALOMAR ASPIRE LASER PLATFORMGEXSubstantially Equivalent
K073583MODIFICATION TO PALOMAR LUX1540 HANDPIECEGEXSubstantially Equivalent
K071768ERBIUM FRACTIONAL HANDPIECEGEXSubstantially Equivalent
K071152PALOMAR ERBIUM HANDPIECEGEXSubstantially Equivalent
K061652PALOMAR LUX1540 HANDPIECEGEXSubstantially Equivalent
K041086PALOMAR STARLUX PULSED LIGHT SYSTEMGEXSubstantially Equivalent
K033549STARLUX PULSED LIGHT SYSTEMGEXSubstantially Equivalent
K024179PALOMAR LIGHTCUBEILYSubstantially Equivalent
K013028PALOMAR SLP 1000GEXSubstantially Equivalent
K982980LIGHTSHEER LONG PULSE RUBY LASERGEXSubstantially Equivalent
K980517EPILASER NORMAL MODE RUBY LASERGEXSubstantially Equivalent
K980420LIGHTSHEERGEXSubstantially Equivalent
K980160EPILASER I UPGRADE KITGEXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain