The following data is part of a premarket notification filed by Alden Optical Labs., Inc. with the FDA for Oxylens (hioxifilcon B) Soft (spherical & Toric) Daily Wear Contact Lenss (clear & Blue Visibility Tinted, Lathe-cut Fr).
| Device ID | K981252 |
| 510k Number | K981252 |
| Device Name: | OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ALDEN OPTICAL LABS., INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing ALDEN OPTICAL LABS., INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-06 |
| Decision Date | 1998-06-23 |
| Summary: | summary |