The following data is part of a premarket notification filed by Largan Medical Co., Ltd. with the FDA for Largan 55 Uv Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens.
Device ID | K182523 |
510k Number | K182523 |
Device Name: | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens |
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 | 2018-09-13 |
Decision Date | 2018-11-01 |
Summary: | summary |