The following data is part of a premarket notification filed by Largan Medical Co., Ltd with the FDA for Largan U38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens For Astigmatism, Largan U38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens For Presbyopia.
| Device ID | K182674 |
| 510k Number | K182674 |
| Device Name: | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens For Astigmatism, Largan U38 (Polymacon) 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 | Amy Tien Largan Medical Co., Ltd 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist., Taichung, TW 40850 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-26 |
| Decision Date | 2018-11-13 |
| Summary: | summary |