The following data is part of a premarket notification filed by Clearlab Pte Ltd. with the FDA for Specialty 55 & Multifocal (methafilcon A) Soft (hydrophilic Contact Lenses For Daily Wear.
| Device ID | K003833 |
| 510k Number | K003833 |
| Device Name: | SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CLEARLAB PTE LTD. 203 NORTH WABASH AVE. SUITE 1200 Chicago, IL 60601 |
| Contact | John M Szabocsik |
| Correspondent | John M Szabocsik CLEARLAB PTE LTD. 203 NORTH WABASH AVE. SUITE 1200 Chicago, IL 60601 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-11 |
| Decision Date | 2001-02-13 |