Gelflex Laboratories
AustraliaFDA applicant, unverified FDA FEI 1000426389
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Gelflex Laboratories makes
Gelflex Laboratories manufactures a range of hydrophilic soft contact lenses, including daily wear and extended-wear designs. Their portfolio includes lenses with varying water content (49% and 55%) and materials such as polymacon, methafilcon A, and hioxifilcon A, as well as tinted and clear options for vision correction.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The company’s products are registered in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000426389
- Address
- 52 MULGUL ROAD MALAGA, PERTH Western Australia
Frequently asked questions
How many devices does Gelflex Laboratories have in the registry?
The registry currently lists 4 devices for Gelflex Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gelflex Laboratories's devices?
Among its 4 most recently registered devices, Gelflex Laboratories has devices listed in FDA 510(k) (4 devices).
What risk classes do Gelflex Laboratories's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Gelflex Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gelflex Laboratories in the registry?
The most recently registered devices listed for Gelflex Laboratories include GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS, GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%, GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS and Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens.