Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Palomar Medical Products, Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
190 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111840 | EMERGE FRACTIONAL LASER | Palomar Medical Products, Inc. | 2011-11-14 | 138 | 0 |
| K091446 | MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE | Palomar Medical Products, Inc. | 2009-10-27 | 165 | 0 |
| K092222 | THERMAPULSE | Palomar Medical Products, Inc. | 2009-08-20 | 28 | 0 |
| K090525 | LOI SYSTEM | Palomar Medical Products, Inc. | 2009-06-01 | 95 | 0 |
| K083900 | ERBIUM FRACTIONAL HANDPIECE | Palomar Medical Products, Inc. | 2009-02-27 | 60 | 0 |
| K083165 | PALOMAR ASPIRE LASER PLATFORM | Palomar Medical Products, Inc. | 2009-02-13 | 109 | 0 |
| K080244 | PALOMAR LUX 1540 HANDPIECE | Palomar Medical Products, Inc. | 2008-06-20 | 141 | 0 |
| K081416 | PALOMAR ASPIRE LASER PLATFORM | Palomar Medical Products, Inc. | 2008-05-29 | 9 | 0 |
| K080567 | PALOMAR ASPIRE LASER PLATFORM | Palomar Medical Products, Inc. | 2008-04-16 | 47 | 0 |
| K073583 | MODIFICATION TO PALOMAR LUX1540 HANDPIECE | Palomar Medical Products, Inc. | 2008-03-26 | 97 | 0 |
| K071768 | ERBIUM FRACTIONAL HANDPIECE | Palomar Medical Products, Inc. | 2007-11-05 | 129 | 0 |
| K071152 | PALOMAR ERBIUM HANDPIECE | Palomar Medical Products, Inc. | 2007-05-25 | 30 | 0 |
| K061652 | PALOMAR LUX1540 HANDPIECE | Palomar Medical Products, Inc. | 2007-02-27 | 259 | 0 |
| K041086 | PALOMAR STARLUX PULSED LIGHT SYSTEM | Palomar Medical Products, Inc. | 2005-01-13 | 262 | 0 |
| K033549 | STARLUX PULSED LIGHT SYSTEM | Palomar Medical Products, Inc. | 2004-03-10 | 119 | 0 |
| K024179 | PALOMAR LIGHTCUBE | Palomar Medical Products, Inc. | 2003-06-04 | 168 | 0 |
| K013028 | PALOMAR SLP 1000 | Palomar Medical Products, Inc. | 2001-12-06 | 87 | 0 |
| K982980 | LIGHTSHEER LONG PULSE RUBY LASER | Palomar Medical Products, Inc. | 1999-03-04 | 190 | 0 |
| K980517 | EPILASER NORMAL MODE RUBY LASER | Palomar Medical Products, Inc. | 1998-07-21 | 161 | 0 |
| K980420 | LIGHTSHEER | Palomar Medical Products, Inc. | 1998-05-04 | 90 | 0 |
| K980160 | EPILASER I UPGRADE KIT | Palomar Medical Products, Inc. | 1998-03-10 | 53 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda