Photo Medex, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Photo Medex, Inc.” (first 2001, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 78 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 | 10 | 10 |
Review panels
Most recent Photo Medex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082721 | LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS | GEX | 2008-10-28 | 41 |
| K073659 | XTRAC ULTRA 2, MODEL AL10000 | GEX | 2008-03-05 | 70 |
| K051428 | VTRAC EXCIMER LAMP SYSTEM | GEX | 2005-08-09 | 69 |
| K041943 | XTRAC XL, MODEL AL8000 | GEX | 2004-10-14 | 87 |
| K040294 | LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 | GEX | 2004-05-05 | 89 |
| K040234 | LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM | GEX | 2004-04-02 | 60 |
| K031451 | XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000 | GEX | 2003-08-01 | 86 |
| K020847 | XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 | GEX | 2002-05-16 | 62 |
| K011382 | XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 | GEX | 2001-08-02 | 87 |
| K003705 | XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 | GEX | 2001-03-01 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Photo Medex, 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.
- Photo Therapeutics Limited (5 510(k)s)
- Photo Therapeutics, Inc. (2 510(k)s)
- Photo Medic Equipment, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Photo Medex, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Photo Medex, Inc.” (first 2001, latest 2008), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Photo Medex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Photo Medex, Inc. is 78 days.
Which FDA product codes appear under Photo Medex, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 10).
Next steps
- See all 10 Photo Medex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Photo Medex, 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.