510(k) K014100
- Device
- OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
- Applicant
- OPUSDENT LTD.
- 510(k) number
- K014100
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-01-08
- Date received
- 2001-12-13
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ARAVA HACOHEN
- Address
- 117 Ahuzah St. Ra'Ananna IL
FDA Registration Numbers#
- 3013697074
- 3013619029
- 1222773
- 1035236
- 3033511105
- 3005099803
- 3014132468
- 3007120647
- 3006546131
- 3001222017
- 3013734919
- 1048735
- 9611036
- 3020756
- 3032916575
- 3043654467
- 2438558
- 3038189188
- 3004069780
- 3016746323
- 3013917867
- 3030090167
- 3010359222
- 3010273372
- 3009746061
- 3014342096
- 3030543531
- 1319639
- 3040278125
- 3012133441
- 3043140693
- 3016181563
- 3019906161
- 3010060157
- 3015262665
- 3006546082
- 3009380063
- 3014980461
- 3012639861
- 3005855240
- 3005515469
- 3025482817
- 3005403788
- 3006716777
- 3009383334
- 1723170
- 3013515803
- 3033905238
- 2247224
- 3043011436
- 3042261306
- 3010822033
- 3007048256
- 3006368133
- 3004884150
- 3009019578
- 3038372243
- 3032147807
- 3010902869
- 2011068
- 3013376016
- 9611516
- 3013404959
- 3011423170
- 1644312
- 3006617841
- 3023344923
- 2183911
- 3015077548
- 3011964664
- 8030392
- 3004450661
- 1038823
- 3009736547
- 3043153468
- 3037966040
- 3003542872
- 3007689716
- 3043729119
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
FDA Review#
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