The following data is part of a premarket notification filed by Alden Optical Labs., Inc. with the FDA for Io2 Spher(mangofilcon A) Soft (hydrophilic) Contact Lens For Daily Wear,io2 Toric (mangofilcon A) Soft (hydrophilic).
| Device ID | K133079 |
| 510k Number | K133079 |
| Device Name: | IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ALDEN OPTICAL LABS., INC. 16576 W. 53RD WAY Golden, CO 80403 |
| Contact | Kevin Randall |
| Correspondent | Kevin Randall ALDEN OPTICAL LABS., INC. 16576 W. 53RD WAY Golden, CO 80403 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2013-12-17 |
| Summary: | summary |