The following data is part of a premarket notification filed by Alden Optical Labs., Inc. with the FDA for Novakone Spherical And Toric Lenses.
| Device ID | K102557 |
| 510k Number | K102557 |
| Device Name: | NOVAKONE SPHERICAL AND TORIC LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ALDEN OPTICAL LABS., INC. 13295 BROADWAY Alden, NY 14004 |
| Contact | Charles H Creighton |
| Correspondent | Charles H Creighton ALDEN OPTICAL LABS., INC. 13295 BROADWAY Alden, NY 14004 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-07 |
| Decision Date | 2011-04-26 |