The following data is part of a premarket notification filed by Pegavision Corporation with the FDA for Aquamax (etafilcon A) Daily Disposable Soft (hydrophilic) Contact Lenses, Aquamax (etafilcon A) Soft (hydrophilic) Contact Lenses.
| Device ID | K211603 |
| 510k Number | K211603 |
| Device Name: | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Pegavision Corporation 2F-1, No. 5 Shing Yeh St Taoyuan, TW 33341 |
| Contact | Estela Lin |
| Correspondent | Estela Lin Pegavision Corporation 2F-1, No. 5 Shing Yeh St Taoyuan, TW 33341 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-24 |
| Decision Date | 2022-02-02 |