Koi, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Koi, Inc. makes
Koi, Inc. manufactures ophthalmic surgical devices including the KOI BLUE FIELD ENTOPTOSCOPE, KOI LACREMAL HOOK & DILATOR, BLADE GAUGE, KOI LACRIMAL INTUBATION SYSTEM, KOI DIAMOND KNIFE, DIAMOND KNIFE, and KOI PACHYMETER.
The company's portfolio includes Class I and Class II devices listed in the FDA 510(k) registry, and Koi, Inc. is based in the US.
Catalogue
Koi Blue Field Entoptoscope Ref K812764
Regimes: 510(k) Registry: 510(k)Koi Lacremal Hook & Dilator Ref K812097
Regimes: 510(k) Registry: 510(k)Blade Gauge Ref K812011
Regimes: 510(k) Registry: 510(k)Koi Lacrimal Intubation System Ref K812010
Regimes: 510(k) Registry: 510(k)Koi Diamond Knife Ref K812450
Regimes: 510(k) Registry: 510(k)Diamond Knife Ref K830366
Regimes: 510(k) Registry: 510(k)Koi Pachymeter Ref K843247
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Koi, Inc. have in the registry?
The registry currently lists 7 devices for Koi, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Koi, Inc.'s devices?
Among its 7 most recently registered devices, Koi, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Koi, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Koi, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Koi, Inc. in the registry?
The most recently registered devices listed for Koi, Inc. include KOI BLUE FIELD ENTOPTOSCOPE, KOI LACREMAL HOOK & DILATOR, BLADE GAUGE and KOI LACRIMAL INTUBATION SYSTEM.