510(k) K180719
- Device
- InMode Diolaze System
- Applicant
- InMode MD Ltd.
- 510(k) number
- K180719
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-14
- Date received
- 2018-03-19
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- 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
- Amit Goren
- Address
- Tabor Bldg., Shaar Yokneam Yokneam IL 20692 20692
FDA Registration Numbers#
- 3025861981
- 2245304
- 3025104654
- 3037874486
- 3001605696
- 3019559090
- 3015452693
- 2521877
- 1318319
- 3019252665
- 1035236
- 3006546131
- 3013503862
- 3015807001
- 3009039068
- 3024753061
- 3043654467
- 3008776882
- 3005350457
- 8040564
- 3007689729
- 3043012074
- 3010281590
- 3016096097
- 9612448
- 3011137372
- 3012294783
- 3014737458
- 3008156177
- 8021543
- 3015077548
- 1225450
- 3027605507
- 3037047060
- 3014384451
- 2939653
- 3004633032
- 3009380063
- 3043012240
- 3042641021
- 3017264244
- 1000121056
- 3016453096
- 2647580
- 3009241253
- 3025379728
- 3010175098
- 3013532143
- 3004529369
- 3010060157
- 3007535734
- 3010822033
- 1644312
- 3030495752
- 3003477135
- 3011877721
- 3009488834
- 3005730446
- 3003790304
- 3004505220
- 1018233
- 3012639861
- 9614977
- 3008720474
- 3005972890
- 3005987567
- 3012669557
- 1319639
- 3038372243
- 3009462521
- 3003610374
- 1000523114
- 3040278150
- 2011171
- 3043657394
- 8010349
- 3007674911
- 3004361445
- 3026038437
Source Documents#
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | 2026-06-18 |
| K261570 | PICOSURE WORKSTATION | Cynosure, LLC | 2026-06-17 |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | 2026-06-04 |
| K260138 | LUNE PureHygiene | Enamel Pure | 2026-05-29 |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | 2026-05-29 |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | 2026-05-21 |
| K260100 | MOSES Raydar™ | Boston Scientific Corporation | 2026-05-18 |
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | 2026-05-11 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies, Slu | 2026-05-04 |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026-04-29 |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | 2026-04-22 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 |
Legacy Summary#
summary
FDA Review#
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