510(k) K253803
- Device
- MILAN System
- Applicant
- Lumenis Be, Ltd.
- 510(k) number
- K253803
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-02
- Date received
- 2025-11-28
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Shlomit Segman
- Address
- Hakidma St. 9, P.O.B 426 Yokneam Ilit IL 2069236 2069236
FDA Registration Numbers#
- 3010187826
- 1418975
- 8010312
- 3048053025
- 3014925413
- 3012470322
- 3030446844
- 1718873
- 3015225571
- 3007842664
- 3010594949
- 3005695724
- 3014262693
- 3010131466
- 3015540957
- 3012818475
- 3007648309
- 1526534
- 3010400367
- 1000122786
- 3001124136
- 3004464325
- 1030489
- 3013886523
- 9611503
- 2183870
- 3008868758
- 3030645016
- 1030451
- 8010177
- 3002807090
- 3043532708
- 2433012
- 3008816935
- 3008791915
- 3016555232
- 3016727307
- 3043226252
- 1418479
- 2219920
- 3048141561
- 9617070
- 3011307265
- 3017405993
- 3016050940
- 3014579024
- 3015453963
- 2182318
- 1220477
- 3013376016
- 2182269
- 3004598644
- 3004111573
- 3012497308
- 3012447612
- 8043746
- 3009513193
- 2182799
- 2028523
- 3011782009
- 3015153469
- 3016087306
- 3013505983
- 3016076698
- 3030153385
- 1828288
- 3007456622
- 3011559089
- 2648666
- 1223422
- 1724474
- 3029895042
- 2087572
- 3004483538
- 2133810
- 8010418
- 1421879
- 1825146
- 3022320321
Source Documents#
Other 510(k) Records For Product Code GEI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254185 | Potenza Prime | Jeisys Medical Incorporated | 2026-09-11 |
| K262364 | Ellian Enigma RF Device | Ellian Corp | 2026-09-02 |
| K253859 | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | 2026-08-27 |
| K252535 | Inno-Switch™ Laparoscopic Instruments | Taiwan Surgical Corporation | 2026-08-25 |
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026-07-22 |
| K253504 | Volnewmer™ | Classys, Inc. | 2026-07-13 |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | 2026-07-01 |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | 2026-06-18 |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026-06-02 |