The following data is part of a premarket notification filed by Alden Optical Labs., Inc. with the FDA for Alden Hp 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden Hp 54 Multifocal &hp 54 Toric Multifocal Contact Lenses.
| Device ID | K091327 |
| 510k Number | K091327 |
| Device Name: | ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ALDEN OPTICAL LABS., INC. 13295 BROADWAY Alden, NY 14004 |
| Contact | Charles Creighton |
| Correspondent | Charles Creighton ALDEN OPTICAL LABS., INC. 13295 BROADWAY Alden, NY 14004 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-05 |
| Decision Date | 2010-06-25 |