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#
- 3021192541
- 8030967
- 3045010542
- 3002808022
- 3011120183
- 3008915316
- 3013557562
- 3005369776
- 3007305485
- 1061124
- 1060680
- 3009903460
- 3006451981
- 3006696607
- 3012639025
- 3011277660
- 3042953831
- 3010157088
- 3011063460
- 3015539532
- 3005857264
- 3007829657
- 3009822485
- 3014193078
- 1030489
- 3007014520
- 3032109
- 1032347
- 3014982808
- 3013820501
- 1527736
- 2133936
- 3012204368
- 3027454635
- 3044777128
- 3014579024
- 3010363436
- 3004638532
- 3013602304
- 3008215723
- 3007648309
- 3010380518
- 9614279
- 2024311
- 3029916132
- 1037007
- 1225798
- 3003455467
- 3017262662
- 3017202975
- 1221826
- 9680660
- 8040537
- 3010806467
- 3007024186
- 9612278
- 3014663814
- 3015231789
- 3010836847
- 8010591
- 1000523114
- 3009746061
- 3006561161
- 2433012
- 1423537
- 3010353867
- 1720747
- 3015460875
- 3004601121
- 8010312
- 3008102042
- 2244478
- 9616675
- 3011989678
- 2182536
- 3006636961
- 3010684280
- 3014980461
- 3012757453
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | 2026-05-21 |
| K260100 | MOSES Raydar™ | Boston Scientific Corporation | 2026-05-18 |
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