510(k) K222485
- Device
- SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
- Applicant
- Ids, Limited
- 510(k) number
- K222485
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-29
- Date received
- 2022-08-17
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- K.Y. Ahn
- Address
- 194, Simgung-Ro, Gwangtan-Myeon, Paju-Si, Gyeonggi-Do KR 10952 10952
FDA Registration Numbers#
- 3013503862
- 3012639861
- 1035236
- 3004497289
- 3032916575
- 3024753061
- 3005695724
- 3023808190
- 1225450
- 3009593803
- 3014310779
- 3007120647
- 1220477
- 3013376016
- 3040278150
- 3004111573
- 3010053203
- 3011782009
- 3047894521
- 3016076698
- 3002807715
- 9614977
- 3010822033
- 1419489
- 3008965332
- 3004378299
- 1725006
- 3004483538
- 3042261306
- 3012294783
- 3010035831
- 3008442971
- 1825146
- 2953684
- 3009649442
- 3026540840
- 3009970070
- 3006555617
- 3019906161
- 2125050
- 3031582430
- 3001222017
- 3014226003
- 3017264244
- 3033524191
- 3035375056
- 3008156177
- 3041275224
- 3043846025
- 3004475754
- 1221543
- 3010627091
- 3025104654
- 2011068
- 3013557562
- 3001431138
- 3023850562
- 3044175602
- 3006985163
- 3006807694
- 3010902869
- 3020611964
- 3027605646
- 3013515803
- 3010724743
- 3021550489
- 8030115
- 3039935725
- 1424263
- 3007085226
- 1928237
- 3005515469
- 3008915316
- 2954354
- 3015262665
- 3005855240
- 3006985208
- 3017200975
- 3003288808
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261562 | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | 2026-09-10 |
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | 2026-09-10 |
| 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 |