Howard Instruments, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Howard Instruments, Inc. makes
Howard Instruments, Inc. manufactures ophthalmic surgical instruments, including the VMATE Model VMM1000 for corneal tissue manipulation, the CBALK-1000 Blade for precise cutting, and the SCMD-1000 for microkeratome applications. The company also produces the Microkeratome or MATE for corneal reshaping procedures and the FOX Medical Diode Laser System (810nm) for laser-based treatments.
The company’s devices are classified under FDA Class I and Class II, with submissions recorded in the FDA’s 510(k) registry. These products are intended for use in surgical and laser-based ophthalmic procedures and are listed under U.S. regulatory requirements.
Catalogue
Vmate Model VMM1000 Ref K030948
510(k) 510(k)Cbalk-1000 Blade Ref K972727
510(k) 510(k)Scmd-1000 Ref K980985
510(k) 510(k)Microkeratome Or The Mate Ref K974598
510(k) 510(k)Fox Medical Diode Laser System 810NM Ref K063104
510(k) 510(k)
Frequently asked questions
How many devices does Howard Instruments, Inc. have in the registry?
The registry currently lists 5 devices for Howard Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Howard Instruments, Inc.'s devices?
Among its 5 most recently registered devices, Howard Instruments, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Howard Instruments, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Howard Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Howard Instruments, Inc. in the registry?
The most recently registered devices listed for Howard Instruments, Inc. include VMATE MODEL VMM1000, CBALK-1000 BLADE, SCMD-1000 and MICROKERATOME OR THE MATE.