NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
Acculens, Inc.
ACCULENS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1720959 | 1720959 | ACCULENS, INC. | 1 | N | 2026-01-01 | 13301 W 43rd Dr Unit 4 Golden CO US 80403 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 220113 | 1459264099 | K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | HQD | 2023-06-16 |
| 220113 | 1165090328 | ||||
| 220113 | 1365755135 | ||||
| 220113 | 1601971419 | ||||
| 220113 | 1772409047 | ||||
| 220113 | 1951239349 | ||||
| 220113 | 2002691231 | ||||
| 220113 | 1216385477 | ||||
| 220113 | 1846631681 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HQD | 1 | 2023-06-16 |