Photo Medex, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Photo Medex, Inc. makes
Photo Medex, Inc. manufactures diode laser systems (models 810, 940, and 980) and carbon dioxide (CO₂) laser systems for medical applications. Their excimer laser portfolio includes systems like the XTRAC Ultra 2, XTRACXL Plus, XTRAC XL, and VTRAC, designed for procedures requiring ultraviolet or high-energy laser treatments.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The company’s products are registered in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Laserpro 810, 940 And 980 Diode Laser Systems Ref K082721
Regimes: 510(k) Registry: 510(k)Xtrac Ultra 2, Model AL10000 Ref K073659
Regimes: 510(k) Registry: 510(k)Xtracxl Plus Excimer Laser System, Model AL7000 Ref K031451
Regimes: 510(k) Registry: 510(k)Xtrac Excimer Laser System, Model Al 7000 Ref K011382
Regimes: 510(k) Registry: 510(k)Xtrac Excimer Laser System, Model AL7000 Ref K003705
Regimes: 510(k) Registry: 510(k)Laserpro CO2 Carbon Dioxide Laser System Ref K040234
Regimes: 510(k) Registry: 510(k)Xtrac Excimer Laser System, Model AL7000 Ref K020847
Regimes: 510(k) Registry: 510(k)Vtrac Excimer Lamp System Ref K051428
Regimes: 510(k) Registry: 510(k)Xtrac Xl, Model AL8000 Ref K041943
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Photo Medex, Inc., the earliest on 2013-01-04 and the most recent on 2015-03-26. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 26 Mar 2015 Z-1516-2015 Class II Terminated The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these devices.
2013
- 4 Jan 2013 Z-0005-2014 Class II Terminated Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Full distribution text
- 4 Jan 2013 Z-0005-2014 Class II Terminated Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Frequently asked questions
How many devices does Photo Medex, Inc. have in the registry?
The registry currently lists 10 devices for Photo Medex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Photo Medex, Inc.'s devices?
Among its 10 most recently registered devices, Photo Medex, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Photo Medex, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Photo Medex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Photo Medex, Inc.?
FDA recall records list 2 recalls initiated by Photo Medex, Inc., the most recent initiated on 26 Mar 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Photo Medex, Inc. in the registry?
The most recently registered devices listed for Photo Medex, Inc. include LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980, LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS, XTRAC ULTRA 2, MODEL AL10000 and XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000.