Summit Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Summit Technology, Inc. makes
Summit Technology, Inc. manufactures ophthalmic diagnostic and surgical devices, including fiberendoscopes for retinal imaging, laser and sclerectomy tips for corneal procedures, and microkeratomes for corneal reshaping. Their portfolio also includes a holmium laser system for ocular tissue ablation and an ophthalmic fiberendoscope with an integrated needleholder for precise surgical applications.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported via 510(k) clearances. Products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Laser And Emphasis Sclerostomy Tip Ref K926470
Regimes: 510(k) Registry: 510(k)Omniview(Tm) Ophthalmic Fiberendo W/Needleholder Ref K912522
Regimes: 510(k) Registry: 510(k)Summit Krumeich-Barraquer Microkeratome Ref K980675
Regimes: 510(k) Registry: 510(k)Omnimed Holmium Laser And Delivery System Ref K915651
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Summit Technology, Inc. have in the registry?
The registry currently lists 5 devices for Summit Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Summit Technology, Inc.'s devices?
Among its 5 most recently registered devices, Summit Technology, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Summit Technology, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Summit Technology, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Summit Technology, Inc. in the registry?
The most recently registered devices listed for Summit Technology, Inc. include SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE, LASER AND EMPHASIS SCLEROSTOMY TIP, OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER and SUMMIT KRUMEICH-BARRAQUER MICROKERATOME.