Optik
Country not established
- Devices
- 6
What Optik makes
Optik manufactures manual surgical instruments and endoscopic imaging systems, including the Titamed Antwerp system for surgical applications, various lightscope sets for illumination, and the Coast video endoscopic imaging system for minimally invasive procedures. Their portfolio also includes laparoscopes and smaller lightscope variants designed for pediatric or compact use.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. Their endoscopic and surgical instruments are listed in the FDA’s 510(k) registry, and the company operates from the United States.
Catalogue
Manual Surgical Instruments For Titamed Antwerp Ref K896589
Regimes: 510(k) Registry: 510(k)Lightscope Set Ref K894557
Regimes: 510(k) Registry: 510(k)Coast Video Endoscopic Imaging System Ref K926166
Regimes: 510(k) Registry: 510(k)Mini Lightscope Set, Lightscope Jr. Set Ref K894558
Regimes: 510(k) Registry: 510(k)Titamed Antwerp System Ref K896404
Regimes: 510(k) Registry: 510(k)Optik Laparoscope Ref K933776
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optik have in the registry?
The registry currently lists 6 devices for Optik. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optik's devices?
Among its 6 most recently registered devices, Optik has devices listed in FDA 510(k) (6 devices).
What risk classes do Optik's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Optik's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optik in the registry?
The most recently registered devices listed for Optik include MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP, LIGHTSCOPE SET, COAST VIDEO ENDOSCOPIC IMAGING SYSTEM and MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET.