510(k) K231797
- Device
- Medifun Lancing Device, Model No. LD-E1
- Applicant
- Medifun Corporation
- 510(k) number
- K231797
- Product code
- QRL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-22
- Date received
- 2023-06-20
- Regulation
- 878.4850
- Classification name
- Multiple Use Blood Lancet For Single Patient Use Only
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Aaron Chen
- Address
- 4f-1, 4f-9, 4f-10, #99, Jingke S. Rd., Nantun Dist., Taichung City TW 408 408
FDA Registration Numbers#
- 9611444
- 3011806823
- 3009498536
- 1000113657
- 3003674698
- 3008789114
- 1832216
- 3010329663
- 3007499349
- 3005644014
- 3026211706
- 3004130086
- 3011121740
- 3030186688
- 1832816
- 3011065399
- 2954323
- 3003422726
- 1058955
- 3003041175
- 3009171251
- 3003741676
- 3013957847
- 8043792
- 8031690
- 8021764
- 3021314645
- 3010160527
- 3015109923
- 3010515547
- 3004183148
- 3005621222
- 3014649053
- 3017500903
- 3006899020
- 3002773714
- 3017520431
- 3004143450
- 9616530
- 3038356900
- 3030626362
- 3021611414
- 3007134734
- 3006532271
- 3005798905
- 3011420269
- 3013298431
- 3013472743
- 3004468256
- 3015058854
- 3012118659
- 3007363438
- 3041276593
- 9613304
- 3011393376
- 3011191255
- 3004145393
- 3011617315
- 1066444
- 3009578786
- 3008191276
- 1058602
- 3006755541
- 3014437893
- 3018940143
- 3034603279
- 3007963752
- 3003723176
- 3024512705
- 3038419886
- 3021186226
- 3010830834
- 9614157
- 3011213605
- 3003348846
- 3013223546
- 3007382160
- 3043013796
- 3008780388
Source Documents#
Other 510(k) Records For Product Code QRL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253706 | Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. | 2025-12-09 |
| K250813 | MICROLET®NEXT 2 Lancing Device | Ascensia Diabetes Care U.S., Inc. | 2025-05-14 |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) | Tianjin Huahong Technology Co., Ltd. | 2024-11-15 |
| K232912 | Facet Aurora Reusable Lancet Base | Facet Technologies, LLC | 2024-01-25 |
| K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-21 |
| K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets | Gostar Co., Ltd. | 2023-01-20 |
| K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-11-30 |
| K223099 | Facet Manatee Reusable Lancing Base | Facet Technologies, LLC | 2022-11-28 |
| K222656 | LDE4 Lancing Device | I-Sens, Inc. | 2022-11-23 |
| K222246 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-21 |
| K222539 | Facet Blood Lancets | Facet Technologies, LLC | 2022-11-18 |
| K221072 | TRUEdraw Lancing Device, Mini Lancing Device | Trividia Health | 2022-10-18 |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | Arkray, Inc. | 2022-10-17 |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | Owen Mumford, Ltd. | 2022-10-03 |
| K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | Bionime Corporation | 2022-09-26 |