510(k) K211681
- Device
- EON
- Applicant
- Dominion Aesthetic Technologies, Inc.
- 510(k) number
- K211681
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-30
- Date received
- 2021-06-01
- 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
- Ahmed Mohammed
- Address
- 2431 Aloma Ave., Suite #225 Winter Park FL US 32792 32792
FDA Registration Numbers#
- 3013602304
- 3026540840
- 3001431138
- 3004505220
- 3031944951
- 3021315370
- 3027619554
- 3012294783
- 3042351542
- 3014980461
- 1222993
- 3008915316
- 3026038437
- 3007120647
- 3007712511
- 3025379728
Source Documents#
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-09-02 |
| K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | 2026-09-01 |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-08-27 |
| K261964 | ECHOLASER X4 | Elesta S.P.A | 2026-08-19 |
| K262070 | Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. | 2026-08-19 |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | 2026-08-11 |
| K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | 2026-07-24 |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026-07-21 |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | 2026-07-17 |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | 2026-07-16 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases