The following data is part of a premarket notification filed by Clearlab Pte Ltd. with the FDA for Aquasoft All-day & All-day T (hioxifilcon A) Daily Wear Contact Lens.
| Device ID | K052290 |
| 510k Number | K052290 |
| Device Name: | AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CLEARLAB PTE LTD. 2214 SANFORD DRIVE, B7 Grand Junction, CO 81505 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing CLEARLAB PTE LTD. 2214 SANFORD DRIVE, B7 Grand Junction, CO 81505 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-23 |
| Decision Date | 2006-05-15 |
| Summary: | summary |