Medical Laser, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Medical Laser, Inc. makes
Medical Laser, Inc. manufactures endoscopic laser systems, including semi-rigid sheaths, laser lithotriptors for stone fragmentation, and endoscope consoles for surgical procedures. Their portfolio includes modified endoscopes (Series 2100, 2200, and 5000 models), laser decompression kits, and an ND:YAG laser system (OPL3) for medical applications. These devices are designed for use in urological, ophthalmic, and orthopedic interventions.
The company’s devices are regulated under FDA pathways, with Class II and Class III classifications. Products are listed via 510(k) and PMA submissions, reflecting their authorised status in the US market. The manufacturer operates from the United States.
Catalogue
Modified Series 2100 Endoscopes Ref K912089
Regimes: 510(k) Registry: 510(k)Medilase Semi-Rigid Instrod Sheath Series AE1000 Ref K912265
Regimes: 510(k) Registry: 510(k)Medilase System 2010l Laser Lithotriptor Ref K895837
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Medilase 5010 Endoscope Console Ref K900380
Regimes: 510(k) Registry: 510(k)Laser Endoscope Disc Decompression Kits Ref K913136
Regimes: 510(k) Registry: 510(k)Medilase Series 2200 Endoscope Ref K901464
Regimes: 510(k) Registry: 510(k)Medilase Series 2100 Endoscope Ref K900894
Regimes: 510(k) Registry: 510(k)Meditec OPL3 Nd:yag Laser Ref P830025
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Medical Laser, Inc. have in the registry?
The registry currently lists 9 devices for Medical Laser, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medical Laser, Inc.'s devices?
Among its 9 most recently registered devices, Medical Laser, Inc. has devices listed in FDA 510(k) (8 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medical Laser, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Medical Laser, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Medical Laser, Inc. in the registry?
The most recently registered devices listed for Medical Laser, Inc. include MODIFIED SERIES 2100 ENDOSCOPES, MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000, MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR and SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200.