Hello,eyes® BIO Plug
Bio Optics Co., Ltd.
BIO OPTICS CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017609685 | 3017609685 | BIO OPTICS CO., LTD. | 1 | N | 2026-01-01 | 14, Galmachi-ro, 288beon-gil Seongnam Gyeonggi KR 13201 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 279427 | 1426451808 | K241229 | Hello,eyes® BIO Plug | LZU | 2024-06-28 |
| 279427 | 1586991735 | ||||
| 279427 | 1704603639 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LZU | 1 | 2024-06-28 |
PMN#
GUDID#
Hello, eyes - Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted into the lacrimal punctum gland to minimize the drainage of tears through the tear duct, thereby alleviating symptoms of dry eye.
2024-07-30
Hello, eyes - Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted into the lacrimal punctum gland to minimize the drainage of tears through the tear duct, thereby alleviating symptoms of dry eye.
2024-07-30
Hello, eyes - Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted into the lacrimal punctum gland to minimize the drainage of tears through the tear duct, thereby alleviating symptoms of dry eye.
2024-07-30