DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens
Tianjin MasterVision Technology Co., Ltd. · Lens, contact, orthokeratology, overnight · Ophthalmic
Open FDA's page for this record- PMA number
- P220015
- Applicant
- Tianjin MasterVision Technology Co., Ltd.
- Street 1
- # 89 Heyuan Rd., Jing-Jin Technology Valley
- Street 2
- 1st Floor # 15 Bldg.
- City
- Tianjin
- Zip
- 301721
- Generic name
- Lens, contact, orthokeratology, overnight
- Trade name
- DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens
- Product code
- NUU
- Advisory committee
- OP
- Advisory committee description
- Ophthalmic
- Expedited review flag
- N
- Date received
- 2022-09-13
- Decision date
- 2026-08-05
- Docket number
- 26M-8713
- Fed reg notice date
- 2026-08-05
- Decision code
- APPR
- Ao 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.
- Harmonized identifiers (openFDA)
- Device name
- Lens, Contact, Orthokeratology, Overnight
- Medical specialty description
- Ophthalmic
- Regulation number
- 886.5916
- Device class
- 3
- Registration number
- 3001190611, 2031102, 3010607087, 9612500, 3033524682, 1065845, 3003062331, 3022988037, 3014769028, 3012719596, 3002830597, 3013398957, 3014175039, 3003357577, 3032010300, 9614761, 3005147469, 1281950, 1313525, 3045320731
- FEI number
- 3001190611, 3010607087, 3033524682, 1317628, 3003062331, 3022988037, 3014769028, 3002807465, 3012719596, 3002830597, 3013398957, 3014175039, 3003357577, 3032010300, 3003040707, 2017777, 3005147469, 1000188353, 1281950, 3045320731