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#
- 3014848720
- 9710524
- 3010131137
- 3012322232
- 3010291427
- 3004122598
- 3006849754
- 9614641
- 3013783488
- 1319639
- 3011070163
- 3010280625
- 1223422
- 3023155873
- 1221541
- 1000121056
- 8040233
- 8010591
- 3009882464
- 3009762450
- 3009051888
- 9681191
- 3010331645
- 1216677
- 1317547
- 3047841690
- 3015225571
- 3027339877
- 3008933393
- 9613563
- 3015460875
- 3017450375
- 8010312
- 3007544634
- 3001614464
- 3019269298
- 3012507533
- 3004044817
- 3009241989
- 3014262693
- 1724474
- 3013700547
- 3008085016
- 3013505638
- 3024021261
- 9616696
- 3013077751
- 2320762
- 3016438694
- 3004483538
- 8030607
- 3013438730
- 3007699067
- 3039167637
- 3006789154
- 3008720584
- 2133810
- 3027267119
- 3038675429
- 1056350
- 3010701628
- 9611612
- 9680515
- 3033715699
- 2529846
- 3014023545
- 1721983
- 3011063460
- 9614434
- 9611827
- 3023706404
- 3008753275
- 3012510750
- 3004777218
- 3004519921
- 1923569
- 9680718
- 3003678543
- 3010353867
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261572 | Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) | Keyue (Hangzhou) Medical Information Technology Co., Ltd. | 2026-10-13 |
| K262346 | CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5) | Wuhan Phomed Technology Co., Ltd. | 2026-10-08 |
| K261692 | Diode Laser Hair Removal Machine (QDTM-03) | Beijing Nubway S&T Co., Ltd. | 2026-10-07 |
| 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 |
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