510(k) K170179
- Device
- LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
- Applicant
- Lumenis Ltd.
- 510(k) number
- K170179
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-09-18
- Date received
- 2017-01-19
- 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
- Amaya De Levie
- Address
- 6 Hakidma St. P.O. Box 240 Yokneam IL 2069204 2069204
FDA Registration Numbers#
- 3038373471
- 3005581016
- 3030543531
- 3033844600
- 3030090167
- 2938889
- 3033274371
- 3005580113
- 3017638059
- 3016076077
- 8030987
- 3007048256
- 1037955
- 9681260
- 3008627763
- 1225450
- 3033273466
- 3009078366
- 3020900954
- 1038823
- 3019906161
- 3033126947
- 9611036
- 3010364538
- 3017065670
- 3038197172
- 3014577013
- 3008805497
- 3002736133
- 3042953831
- 3030418454
- 3011782009
- 3006985163
- 3013602304
- 3015433394
- 3016405041
- 3026360847
- 3005205318
- 1222993
- 3010683226
- 3033482500
- 3043012240
- 3006546082
- 3017125161
- 3030230686
- 3019252665
- 9612448
- 2134812
- 3012639861
- 3004374705
- 1222773
- 3014980477
- 3013557562
- 3011514163
- 3013121972
- 3013917867
- 3015262665
- 3007674911
- 3010822033
- 3010972758
- 3030125922
- 3011657089
- 3043127589
- 2031763
- 3011423170
- 3030420005
- 2032112
- 3033891767
- 3004475754
- 3012157621
- 3009970070
- 2183744
- 1060848
- 3004505220
- 3020756
- 3033884002
- 3003082988
- 3033511105
- 3033905238
Source Documents#
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary