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| Device | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens |
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| Generic Name | Lens, contact, orthokeratology, overnight |
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| Regulation Number | 886.5916 |
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| Applicant | Tianjin MasterVision Technology Co., Ltd.
# 89 Heyuan Rd., Jing-Jin Technology Valley
1st Floor # 15 Bldg.
Tianjin 301721 |
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| PMA Number | P220015 |
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| Date Received | 09/13/2022 |
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| Decision Date | 08/05/2026 |
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| Product Code |
NUU |
| Docket Number | 26M-8713 |
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| Notice Date | 08/05/2026 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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