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#
- 3003935342
- 1222140
- 3015974593
- 3026606306
- 3005075853
- 3001431138
- 3010687973
- 3019569846
- 3007421149
- 1418975
- 3012453745
- 9614279
- 3009736547
- 1319639
- 3004940677
- 3010885402
- 3014004349
- 3029754081
- 3011683674
- 1223422
- 1222993
- 3010164891
- 3007748793
- 3010361165
- 8040510
- 3005646850
- 3010684280
- 8040537
- 3016678045
- 1421879
- 1423537
- 3000268902
- 3009183442
- 3006017180
- 9610617
- 3003767927
- 3012783431
- 3011024991
- 3036773433
- 3008264458
- 3012818475
- 3012616488
- 2521453
- 9710058
- 3030412764
- 1412854
- 2133936
- 3003418325
- 3011063460
- 2084346
- 3003072803
- 3012428212
- 3013700547
- 2183613
- 8030607
- 3016813690
- 3004837686
- 3002808022
- 3011559089
- 3003687489
- 3042272797
- 8010418
- 3017892510
- 3045753434
- 3013176080
- 3002808227
- 3013789508
- 2087572
- 3013820501
- 1061124
- 3015151147
- 3030626857
- 3006950086
- 3015286855
- 3006897899
- 3016555232
- 3016607092
- 8010298
- 3042940623
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | 2026-09-24 |
| K241973 | SmartIPL_NI System | Lumenis Be, Ltd. | 2026-09-19 |
| K252723 | Dynamis Pro Family | Fotona D.O.O. | 2026-09-19 |
| K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | 2026-09-18 |
| K261673 | LED Therapy Device (QLXY-01) | Beijing Nubway S&T Co., Ltd. | 2026-09-17 |
| K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-09-17 |
| K262877 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | 2026-09-16 |
| 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 |
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