The following data is part of a premarket notification filed by Pegavision Corporation with the FDA for Aquamax (etafilcon A) Bi-weekly Disposable Soft (hydrophilic) Contact Lenses.
| Device ID | K140025 |
| 510k Number | K140025 |
| Device Name: | AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Pegavision Corporation 2F-1 NO.5, SHING YEH ST. SHAN DING VIL. Taoyuan, TW 33341 |
| Contact | Tony Hsu |
| Correspondent | Tony Hsu Pegavision Corporation 2F-1 No. 5, Shing Yeh St. Shan Ding Vil Kwei Shan Hsiang, Taoyuan Hsien, TW 333 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-06 |
| Decision Date | 2014-10-15 |
| Summary: | summary |