The following data is part of a premarket notification filed by Largan Medical Co. Ltd. with the FDA for Largan 55 Uv (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 Uv (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens For Astigmatism, Largan 55 Uv (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens For Presbyopia.
| Device ID | K181232 |
| 510k Number | K181232 |
| Device Name: | Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens For Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens For Presbyopia |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Largan Medical Co. Ltd. 2F, No 14, 23rd RD. Taichung Industrial Park, Nantun Dist. Taichung, TW 40850 |
| Contact | Amy Tien |
| Correspondent | Jennifer Ting Jens Medical Consulting Ltd. 6F, No. 39, Ln 224, Jixian Rd., Luzhou Dist. New Taipei City, TW 247 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-09 |
| Decision Date | 2018-06-29 |
| Summary: | summary |