The following data is part of a premarket notification filed by Igel Vision Care Pte Ltd. with the FDA for Igel 55uv (methafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear,igel 55 Uv Multifocal (methafilcon A) Soft.
| Device ID | K020855 |
| 510k Number | K020855 |
| Device Name: | IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | IGEL VISION CARE PTE LTD. 201 KING ARTHUR COURT Tracy, CA 95376 |
| Contact | Debbie Mcintire |
| Correspondent | Debbie Mcintire IGEL VISION CARE PTE LTD. 201 KING ARTHUR COURT Tracy, CA 95376 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-15 |
| Decision Date | 2002-06-04 |
| Summary: | summary |