Palomar Medical Technologies, Inc.
Cary, NC, US
Palomar Medical Technologies, Inc. appears in FDA device records in Cary, NC. FDA records list 24 510(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
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Palomar Medical Technologies, Inc. between 2000 and 2013. The busiest year on record is 2001, with 4. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130250 | QYAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K120622 | PALOMAR VECTUS LASER | GEX | Substantially Equivalent | |
| K110907 | PALOMAR ICON (TM) AESTHETIC SYSTEM | GEX | Substantially Equivalent | |
| K103664 | PRIMUS AESTHETIC PLATFORM | ONG | Substantially Equivalent | |
| K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | ONG | Substantially Equivalent | |
| K100270 | ARTISAN AESTHETIC SYSTEM | GEX | Substantially Equivalent | |
| K090195 | PALOMAR LUX1540 HANDPIECE | GEX | Substantially Equivalent | |
| K070298 | MODIFICATION TO PALOMAR LUXIR HANDPIECE | GEX | Substantially Equivalent | |
| K063571 | PALOMAR LUX2940 HANDPIECE | GEX | Substantially Equivalent | |
| K060839 | ABC HAIR REMOVAL SYSTEM | OHT | Substantially Equivalent | |
| K061436 | PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K060301 | PALOMAR LUX1540 HANDPIECE | GEX | Substantially Equivalent | |
| K060069 | PALOMAR LUXIR FRACTIONAL HANDPIECE | GEX | Substantially Equivalent | |
| K050370 | PALOMAR LUXIR HANDPIECE | ILY | Substantially Equivalent | |
| K041879 | PALOMAR LUX1064 HANDPIECE | GEX | Substantially Equivalent | |
| K040081 | PALOMAR LUXV HANDPIECE | GEX | Substantially Equivalent | |
| K023967 | PALOMAR Q-YAG ND:YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K020453 | PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER | GEX | Substantially Equivalent | |
| K011747 | PALOMAR LC 100 DIODE LASER | GEX | Substantially Equivalent | |
| K010580 | PALOMAR SLP 1000 | GEX | Substantially Equivalent | |
| K003886 | PALOMAR SPALIGHT PULSED LIGHT SYSTEM | GEX | Substantially Equivalent | |
| K003460 | PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K002649 | ARAMIS DERMATOLOGICAL LASER | GEX | Substantially Equivalent | |
| K994225 | PALOMAR SLP 2000 | GEX | Substantially 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