The following data is part of a premarket notification filed by Pegavision Corporation with the FDA for Pegavision (etafilcon A) Color Daily Disposable Soft (hydrophilic) Contact Lenses, Pegavision (etafilcon A) Color Soft (hydrophilic) Contact Lenses.
| Device ID | K200296 |
| 510k Number | K200296 |
| Device Name: | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color 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 | 2020-02-06 |
| Decision Date | 2020-10-15 |