510(k) K900332
- Device
- EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
- Applicant
- 3M COMPANY
- 510(k) number
- K900332
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-13
- Date received
- 1990-01-23
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- JULIA WANNAMAKER
- Address
- Chemolite Blvd. & Washington City Rd. 19 Cottae Grove MN US 55016 55016
FDA Registration Numbers#
- 1926681
- 9614434
- 3014461810
- 3006716777
- 3007748793
- 3027339877
- 3007029079
- 3015539532
- 3027339887
- 1720747
- 3003418325
- 3011625895
- 3017210488
- 1720929
- 8010298
- 1718850
- 3009763019
- 3006059917
- 3013188547
- 3007712511
- 3016813690
- 3033524168
- 8010591
- 3010226575
- 3044156918
- 3015895145
- 3010305275
- 3010288205
- 3013111980
- 3010816547
- 8030967
- 3010173425
- 3013438730
- 9617070
- 1222780
- 9680357
- 3010356635
- 3004754983
- 2031093
- 3013077751
- 3010621964
- 3014982808
- 3038675429
- 1018233
- 3035642068
- 1060680
- 3009423112
- 3009183442
- 3009609358
- 3006498370
- 3006696607
- 8010877
- 2183785
- 3012510750
- 8010890
- 3012606445
- 3008132398
- 3015515531
- 3009513193
- 9616666
- 1225492
- 2648623
- 1211998
- 3009905888
- 3031240334
- 3015506965
- 3031571464
- 3030412764
- 3004111573
- 3028977843
- 3011879048
- 2183715
- 3015779311
- 3015449142
- 3015540957
- 2648666
- 3012616488
- 3005334138
- 3012995405
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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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