K241229 is an FDA 510(k) clearance for the Hello,eyes® BIO Plug. This device is classified as a Plug, Punctum.
Submitted by Bio Optics Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on June 28, 2024, 57 days after receiving the submission on May 2, 2024.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K241229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2024 |
| Decision Date | June 28, 2024 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU - Plug, Punctum |
| Device Class | - |