510(k) K254290
- Device
- ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
- Applicant
- Shenzhen Peninsula Medical Group
- 510(k) number
- K254290
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-30
- Date received
- 2025-12-31
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Chunyan Zhang
- Address
- 101 1 F Block B, 3f Block B, 3f Block A, Bldg, F2 Changfeng Industrial Park, Liuxian 3rd Rd., 68# Xin'An St. Bao'An Dist Shenzhen CN 518100 518100
FDA Registration Numbers
- 3002808148
- 1450662
- 3005677568
- 3038715747
- 3010288205
- 3010402752
- 3016087306
- 3013820501
- 3026612481
- 3030926959
- 3007593944
- 3013917867
- 3030495752
- 3010377594
- 3008720584
- 3015515531
- 3011277660
- 8040537
- 9614969
- 3004464325
- 9617429
- 1421101
- 3008933393
- 3007047889
- 3015453963
- 2183744
- 3013188547
- 3012757453
- 3030230686
- 3007007790
- 3012259264
- 3008805497
- 3014939461
- 3020142587
- 1216677
- 9612074
- 2938071
- 1651252
- 3009241989
- 1313525
- 3009822485
- 2649614
- 2031093
- 3030447506
- 1643264
- 3011050570
- 3007353760
- 1051614
- 3013376016
- 1319660
- 2085947
- 1423537
- 1718850
- 3008843439
- 3010305275
- 3033589330
- 3006950086
- 8043398
- 3003678543
- 2028523
- 3027339877
- 8010877
- 8010890
- 1064858
- 3017210488
- 2126666
- 3002807314
- 3007675948
- 3010687973
- 2916714
- 3009756327
- 3011120183
- 8010177
- 3007113251
- 2424366
- 3030733800
- 3007305485
- 3004904811
- 3004530184
Source Documents
Other 510(k) Records For Product Code GEI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253917 | ARION ARC System | Plasma Surgical, Inc. | 2026-04-10 |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026-04-07 |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026-04-06 |
| K253405 | Prana System | Prana Surgical | 2026-04-01 |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | 2026-03-30 |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | 2026-03-27 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | 2026-03-25 |
| K253750 | BTL-785NEH | BTL Industries, Inc. | 2026-03-17 |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | 2026-03-02 |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | 2026-02-24 |
| K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | 2026-02-11 |
| K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | 2026-02-06 |
| K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2026-01-27 |
| K251435 | InbellaIgnite RF System | Inbella Medical, Inc. | 2026-01-27 |