The following data is part of a premarket notification filed by Clearlab Pte Ltd. with the FDA for Mieru (etafilcon A) Daily Wear Contact Lens Clear And Visibility Tint, With Uv Blocker.
| Device ID | K030167 |
| 510k Number | K030167 |
| Device Name: | MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER |
| 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 | 2003-01-16 |
| Decision Date | 2003-04-02 |
| Summary: | summary |