Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Palomar Medical Technologies, Inc. · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
196 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130250 | QYAG LASER SYSTEM | Palomar Medical Technologies, Inc. | 2013-05-03 | 91 | 0 |
| K120622 | PALOMAR VECTUS LASER | Palomar Medical Technologies, Inc. | 2012-05-23 | 83 | 0 |
| K110907 | PALOMAR ICON (TM) AESTHETIC SYSTEM | Palomar Medical Technologies, Inc. | 2011-06-22 | 83 | 0 |
| K103664 | PRIMUS AESTHETIC PLATFORM | Palomar Medical Technologies, Inc. | 2011-03-17 | 91 | 0 |
| K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | Palomar Medical Technologies, Inc. | 2010-09-01 | 92 | 0 |
| K100270 | ARTISAN AESTHETIC SYSTEM | Palomar Medical Technologies, Inc. | 2010-03-29 | 59 | 0 |
| K090195 | PALOMAR LUX1540 HANDPIECE | Palomar Medical Technologies, Inc. | 2009-11-20 | 297 | 0 |
| K070298 | MODIFICATION TO PALOMAR LUXIR HANDPIECE | Palomar Medical Technologies, Inc. | 2007-07-03 | 153 | 0 |
| K063571 | PALOMAR LUX2940 HANDPIECE | Palomar Medical Technologies, Inc. | 2007-02-09 | 72 | 0 |
| K060839 | ABC HAIR REMOVAL SYSTEM | Palomar Medical Technologies, Inc. | 2006-12-07 | 254 | 0 |
| K061436 | PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM | Palomar Medical Technologies, Inc. | 2006-12-06 | 196 | 0 |
| K060301 | PALOMAR LUX1540 HANDPIECE | Palomar Medical Technologies, Inc. | 2006-03-23 | 45 | 0 |
| K060069 | PALOMAR LUXIR FRACTIONAL HANDPIECE | Palomar Medical Technologies, Inc. | 2006-03-02 | 52 | 0 |
| K050370 | PALOMAR LUXIR HANDPIECE | Palomar Medical Technologies, Inc. | 2005-06-15 | 121 | 0 |
| K041879 | PALOMAR LUX1064 HANDPIECE | Palomar Medical Technologies, Inc. | 2005-01-13 | 185 | 0 |
| K040081 | PALOMAR LUXV HANDPIECE | Palomar Medical Technologies, Inc. | 2004-04-01 | 77 | 0 |
| K023967 | PALOMAR Q-YAG ND:YAG LASER SYSTEM | Palomar Medical Technologies, Inc. | 2003-01-27 | 59 | 0 |
| K020453 | PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER | Palomar Medical Technologies, Inc. | 2002-05-10 | 88 | 0 |
| K011747 | PALOMAR LC 100 DIODE LASER | Palomar Medical Technologies, Inc. | 2001-08-30 | 86 | 0 |
| K010580 | PALOMAR SLP 1000 | Palomar Medical Technologies, Inc. | 2001-05-22 | 84 | 0 |
| K003886 | PALOMAR SPALIGHT PULSED LIGHT SYSTEM | Palomar Medical Technologies, Inc. | 2001-03-01 | 73 | 0 |
| K003460 | PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM | Palomar Medical Technologies, Inc. | 2001-01-25 | 79 | 0 |
| K002649 | ARAMIS DERMATOLOGICAL LASER | Palomar Medical Technologies, Inc. | 2000-11-21 | 89 | 0 |
| K994225 | PALOMAR SLP 2000 | Palomar Medical Technologies, Inc. | 2000-05-18 | 155 | 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