510(k) K230759
- Device
- SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
- Applicant
- Bosungmeditech Co., Ltd.
- 510(k) number
- K230759
- Product code
- QRK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-13
- Date received
- 2023-03-20
- Regulation
- 878.4850
- Classification name
- Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- 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
- Yang Ho Song
- Address
- #F, 107 Donghwagongdan-Ro, Munmak-Eup Wonju KR
FDA Registration Numbers#
- 3002807408
- 3011806823
- 3009498536
- 3004637226
- 1000113657
- 3003674698
- 3008789114
- 3016450032
- 1832216
- 3007499349
- 3005644014
- 3026211706
- 3004130086
- 3011121740
- 3016525500
- 3030186688
- 3009498548
- 1832816
- 3011065399
- 2954323
- 1058955
- 3009171251
- 3003741676
- 3013957847
- 8031690
- 8021764
- 3021314645
- 3015109923
- 3010515547
- 3014649053
- 3017500903
- 3006899020
- 3002773714
- 3017520431
- 3004143450
- 9616530
- 3038356900
- 3030626362
- 3024273968
- 3021611414
- 3007134734
- 3006532271
- 3005798905
- 3004146366
- 3011420269
- 3008102042
- 2416465
- 3013472743
- 3004468256
- 3015058854
- 3012118659
- 3007363438
- 9613304
- 3011393376
- 3011191255
- 3004145393
- 3011617315
- 1066444
- 3009578786
- 3008191276
- 1058602
- 3006755541
- 3018940143
- 3034603279
- 3006142663
- 3003723176
- 3024512705
- 3038419886
- 3021186226
- 9614157
- 3014312726
- 3011213605
- 3003348846
- 3013223546
- 3007382160
- 3043013796
- 3020976354
- 3008780388
- 1810909
Source Documents#
Other 510(k) Records For Product Code QRK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250016 | droplet® personal lancets | Htl-Strefa S.A | 2025-07-01 |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| K242622 | Sterile Lancets for Single Use | Ningbo Caremed Medical Products Co., Ltd. | 2024-10-28 |
| K241810 | MICROLET®NEXT Lancet | Ascensia Diabetes Care U.S., Inc. | 2024-08-15 |
| K232330 | Lancing System | Ningbo Medsun Medical Co., Ltd. | 2024-01-04 |
| K230712 | SG Lanset I, SG Lancets, Soft Lancets | Sewon Medical Co. | 2023-12-06 |
| K230310 | STAT Medical Device Lancing System | Stat Medical Devices | 2023-09-08 |
| K222617 | EasyTouch Lancing Device | Stat Medical Devices | 2023-03-21 |
| K223815 | ONE DROP Lancing Device | Stat Medical Devices | 2023-02-15 |
| K223314 | Disposable Blood Lancets | Huaian Hening Medical Instruments Co., Ltd. | 2023-01-25 |
| K223480 | Medipoint Blood Lancets | Medipoint Holdings, LLC | 2023-01-13 |
| K221383 | MedtFine Blood Lancet | Shanghai Carelife International Trading Co. , Ltd. | 2022-09-21 |
| K221507 | Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | 2022-08-31 |
| K221433 | Facet 28G Universal Lancet | Facet Technologies, LLC | 2022-07-15 |