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#
- 3008361498
- 1221934
- 3005528784
- 3007515069
- 3002250546
- 3001592626
- 3010305275
- 9710649
- 2245304
- 1037007
- 3005110411
- 3008843439
- 9681383
- 3016099036
- 3005382983
- 1418975
- 1047843
- 3005595283
- 3013500228
- 3035374386
- 1724474
- 2182318
- 3010432890
- 3019924
- 3038675429
- 3011879048
- 3012329552
- 9611112
- 3024712917
- 3020142587
- 3005857264
- 3008816935
- 2529846
- 3007593944
- 3016813690
- 3014421917
- 3006498370
- 3007738736
- 3013421458
- 1923569
- 3011586151
- 2650143
- 3015972753
- 2649614
- 1722040
- 3043585137
- 8010312
- 9610612
- 3005350457
- 3010226575
- 3011625895
- 3007421149
- 3011230048
- 3011944170
- 3004598644
- 3007766590
- 3009599228
- 3010291427
- 3005075853
- 2030598
- 3006639944
- 3011137372
- 3013596024
- 3015231789
- 3006561161
- 1055236
- 3012757453
- 3040335671
- 3003687489
- 3007200016
- 9616696
- 3015453963
- 3004878380
- 3008998256
- 3009380063
- 1319660
- 3030447506
- 3012263546
- 3030176940
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026-04-29 |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | 2026-04-22 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 |
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