The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Lde4 Lancing Device.
| Device ID | K222656 |
| 510k Number | K222656 |
| Device Name: | LDE4 Lancing Device |
| Classification | Multiple Use Blood Lancet For Single Patient Use Only |
| Applicant | i-SENS, Inc. 43, Banpo-Daero 28-Gil, Seocho-Gu, Seoul, KR 06646 |
| Contact | H.S. Yoo |
| Correspondent | H.S. Yoo i-SENS, Inc. 43, Banpo-Daero 28-Gil, Seocho-Gu, Seoul, KR 06646 |
| Product Code | QRL |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-02 |
| Decision Date | 2022-11-23 |