Acculens, Inc. · Class II · Cleared Jun 16, 2023
| K-number | K230910 |
| Device name | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens |
| Applicant | Acculens, Inc. |
| Product code | HQD |
| Device class | Class II |
| Decision date | Jun 16, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 886.5916 |
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