The following data is part of a premarket notification filed by Largan Medical Co., Ltd. with the FDA for Largan Db / Db Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan Db / Db Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens For Astigma, Largan Db / Db Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens Fo.
| Device ID | K202129 |
| 510k Number | K202129 |
| Device Name: | Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens For Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens Fo |
| 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 | 2020-07-31 |
| Decision Date | 2021-04-01 |