The following data is part of a premarket notification filed by Clearlab Sg Pte Ltd. with the FDA for Clear1-day Hioxifilcon Daily Disposable Soft Contact Lens.
| Device ID | K080632 |
| 510k Number | K080632 |
| Device Name: | CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS |
| Classification | Lens, Contact, (disposable) |
| Applicant | CLEARLAB SG PTE LTD. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing CLEARLAB SG PTE LTD. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-05 |
| Decision Date | 2008-10-15 |
| Summary: | summary |