510(k) K233642
- Device
- InMode RF System
- Applicant
- InMode , Ltd.
- 510(k) number
- K233642
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-20
- Date received
- 2023-11-13
- 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
- No
Applicant Contact#
- Contact
- Suhair Francis
- Address
- Tabor Bldg., Shaar Yokneam Pob 44 Yokneam Illit IL 2069200 2069200
FDA Registration Numbers#
- 3008361498
- 1221934
- 3005528784
- 3007515069
- 3002250546
- 3001592626
- 3010305275
- 9710649
- 2245304
- 1037007
- 3005110411
- 3008843439
- 9681383
- 3016099036
- 3005382983
- 1418975
- 1047843
- 3005595283
- 3013500228
- 3035374386
- 1724474
- 2182318
- 3010432890
- 3019924
- 3038675429
- 3011879048
- 3012329552
- 9611112
- 3024712917
- 3020142587
- 3005857264
- 3008816935
- 2529846
- 3007593944
- 3016813690
- 3014421917
- 3006498370
- 3007738736
- 3013421458
- 1923569
- 3011586151
- 2650143
- 3015972753
- 2649614
- 1722040
- 3043585137
- 8010312
- 9610612
- 3005350457
- 3010226575
- 3011625895
- 3007421149
- 3011230048
- 3011944170
- 3004598644
- 3007766590
- 3009599228
- 3010291427
- 3005075853
- 2030598
- 3006639944
- 3011137372
- 3013596024
- 3015231789
- 3006561161
- 1055236
- 3012757453
- 3040335671
- 3003687489
- 3007200016
- 9616696
- 3015453963
- 3004878380
- 3008998256
- 3009380063
- 1319660
- 3030447506
- 3012263546
- 3030176940
Source Documents#
Other 510(k) Records For Product Code GEI#
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| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 |