Device Dossier
Orthokeratology contact lens
Device Dossier for Orthokeratology contact lens (Orthokeratology contact lens, Class IIa, sponsor Gelflex Laboratories). ARTG record, intended purpose,…
- GMDN category: Orthokeratology contact lens
Intended purpose
A rigid-gas-permeable ophthalmic lens intended to be worn directly against the cornea of the eye for orthokeratology (Ortho-K), a procedure where the lens is worn for several hours, typically each night, to modify the curvature of the cornea as an alternative method to correct refractive vision conditions. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.