The following data is part of a premarket notification filed by Innova Vision Inc. with the FDA for Innova Vision Hydrogel (hioxifilcon A) Soft (hydrophilic) Contact Lens.
| Device ID | K213119 |
| 510k Number | K213119 |
| Device Name: | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Innova Vision Inc. 2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park Hsinchu, TW 300091 |
| Contact | Kari Huang |
| Correspondent | Kari Huang Innova Vision Inc. 2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park Hsinchu, TW 300091 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2022-05-13 |