Data / Medical devices / Australia / Gelflex Laboratories
Gelflex Laboratories: FDA-registered device maker in PERTH Western Australia, Australia, 3 510(k) clearances
Gelflex Laboratories is registered with the FDA (registration 9680540) in PERTH Western Australia, Australia. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 6, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680540
- FEI number
- 1000426389
- Address
- 52 Mulgul Road Malaga, PERTH Western Australia, Australia, 6090
- Owner or operator
- GELFLEX LABORATORIES (9009649)
- Roles
- Complaint file establishment, Contract manufacturer
- First device listed
- January 15, 2008
- Registered through
- 2026
- Brand names listed
- Gamma, Delta. Alpha, Lumenis, Phantasee, Maxvue Hydrosoft, Dimple, Flash, Sofclear, Synergy, Gelflex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Complaint file establishment | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Complaint file establishment | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 6, 2018 | K181558 | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens | LPL | Substantially Equivalent | Gelflex Laboratories | accessdata.fda.gov |
| April 1, 2003 | K030027 | GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% | LPL | Substantially Equivalent | Gelflex Laboratories | accessdata.fda.gov |
| February 5, 2003 | K024003 | GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT | LPL | Substantially Equivalent | Gelflex | accessdata.fda.gov |
Compare with other makers
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Updated September 6, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.