PMA P220015
- Device
- DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens
- Applicant
- Tianjin MasterVision Technology Co., Ltd.
- PMA number
- P220015
- Product code
- NUU
- Decision date
- 2026-08-05
- Classification
- Ophthalmic
- Generic name
- Lens, contact, orthokeratology, overnight
- Approval order statement
- Approval for DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens. The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lens is indicated for overnight wear for the temporary reduction of myopia up to 4.00 diopters (manifest spherical equivalent) in eyes with astigmatism up to 1.50 diopters. The lenses may only be disinfected using a chemical disinfection system. Note: To maintain the Orthokeratology effect overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e.g., night driving), cause visual fluctuations, and changes in intended correction.
Current openFDA PMA Record#
- Device
- DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens
- Applicant
- Tianjin MasterVision Technology Co., Ltd.
- PMA number
- P220015
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2026-08-05
- Decision code
- APPR
- Date received
- 2022-09-13
- Approval order statement
- Approval for DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens. The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lens is indicated for overnight wear for the temporary reduction of myopia up to 4.00 diopters (manifest spherical equivalent) in eyes with astigmatism up to 1.50 diopters. The lenses may only be disinfected using a chemical disinfection system. Note: To maintain the Orthokeratology effect overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e.g., night driving), cause visual fluctuations, and changes in intended correction.