Palomar Medical Products, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Palomar Medical Products, Inc.” (first 1998, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 109 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 | 0 | — |
| 2013 | 0 | — |
| 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 | 16 | 16 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 3 | 3 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 | 2 |
Review panels
Most recent Palomar Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111840 | EMERGE FRACTIONAL LASER | ONG | 2011-11-14 | 138 |
| K091446 | MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE | ONG | 2009-10-27 | 165 |
| K092222 | THERMAPULSE | ILY | 2009-08-20 | 28 |
| K090525 | LOI SYSTEM | ONG | 2009-06-01 | 95 |
| K083900 | ERBIUM FRACTIONAL HANDPIECE | GEX | 2009-02-27 | 60 |
| K083165 | PALOMAR ASPIRE LASER PLATFORM | GEX | 2009-02-13 | 109 |
| K080244 | PALOMAR LUX 1540 HANDPIECE | GEX | 2008-06-20 | 141 |
| K081416 | PALOMAR ASPIRE LASER PLATFORM | GEX | 2008-05-29 | 9 |
| K080567 | PALOMAR ASPIRE LASER PLATFORM | GEX | 2008-04-16 | 47 |
| K073583 | MODIFICATION TO PALOMAR LUX1540 HANDPIECE | GEX | 2008-03-26 | 97 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Palomar Medical Products, 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 Technologies, Inc. (24 510(k)s)
- Palomar (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Palomar Medical Products, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Palomar Medical Products, Inc.” (first 1998, latest 2011), across 3 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 Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Palomar Medical Products, Inc. is 109 days.
Which FDA product codes appear under Palomar Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 16); ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output, 3); ILY (Lamp, Infrared, Therapeutic Heating, 2).
Next steps
- See all 21 Palomar Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Palomar Medical Products, 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.