Palomar Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Palomar Medical Technologies, Inc.” (first 2000, latest 2013), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 83 |
| 2013 | 1 | 91 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 20 | 20 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 2 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| OHT | Light Based Over-The-Counter Hair Removal | 1 | 1 |
Review panels
Most recent Palomar Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130250 | QYAG LASER SYSTEM | GEX | 2013-05-03 | 91 |
| K120622 | PALOMAR VECTUS LASER | GEX | 2012-05-23 | 83 |
| K110907 | PALOMAR ICON (TM) AESTHETIC SYSTEM | GEX | 2011-06-22 | 83 |
| K103664 | PRIMUS AESTHETIC PLATFORM | ONG | 2011-03-17 | 91 |
| K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | ONG | 2010-09-01 | 92 |
| K100270 | ARTISAN AESTHETIC SYSTEM | GEX | 2010-03-29 | 59 |
| K090195 | PALOMAR LUX1540 HANDPIECE | GEX | 2009-11-20 | 297 |
| K070298 | MODIFICATION TO PALOMAR LUXIR HANDPIECE | GEX | 2007-07-03 | 153 |
| K063571 | PALOMAR LUX2940 HANDPIECE | GEX | 2007-02-09 | 72 |
| K060839 | ABC HAIR REMOVAL SYSTEM | OHT | 2006-12-07 | 254 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Palomar Medical Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Palomar Medical Products, Inc. (21 510(k)s)
- Palomar (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Palomar Medical Technologies, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Palomar Medical Technologies, Inc.” (first 2000, latest 2013), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Palomar Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Palomar Medical Technologies, Inc. is 87 days.
Which FDA product codes appear under Palomar Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 20); ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output, 2); ILY (Lamp, Infrared, Therapeutic Heating, 1).
Next steps
- See all 24 Palomar Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Palomar Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.