510(k) K180967
- Device
- Dental Diode Laser System
- Applicant
- Lazon Medical Laser Co., Ltd.
- 510(k) number
- K180967
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-11
- Date received
- 2018-04-13
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Gen Cheng
- Address
- #123, Hezuo St., Dadong District Shenyang CN 110179 110179
FDA Registration Numbers
- 3038715747
- 1725006
- 3018116888
- 3013917867
- 3023344923
- 3030495752
- 1054713
- 3030233762
- 3011657089
- 3010060157
- 1221275
- 3012452798
- 3019906161
- 2438558
- 2183744
- 3020611964
- 2939653
- 3009039068
- 3030230686
- 3008805497
- 1216677
- 3005801723
- 3003610374
- 2938071
- 3032916575
- 1313525
- 3011050570
- 3003015433
- 3013376016
- 3015392301
- 3020770009
- 8044098
- 2027755
- 3009488834
- 3011302631
- 3008442971
- 1064858
- 1225072
- 3002807314
- 1045254
- 1419489
- 3017124433
- 3043011436
- 3030733800
- 3004378299
- 3013602304
- 8021543
- 8040564
- 3016453004
- 3007336385
- 3043047259
- 3009649442
- 1723170
- 1226486
- 3017200975
- 3011743768
- 3013041594
- 3006368133
- 3015313684
- 3029083714
- 3014561425
- 3036240802
- 3016413636
- 3008915316
- 3016170453
- 3021550489
- 3009298127
- 3014980477
- 3005210579
- 2032112
- 3016830208
- 2954354
- 3011670002
- 9610617
- 3034630389
- 3009462521
- 3008925277
- 2953684
- 3042261306
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06970750060163 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060156 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060149 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060132 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060125 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060118 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060101 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060095 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060088 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060071 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060064 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060057 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060040 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060033 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060026 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
| 06970750060019 | Dental Diode Laser System | LAZON Medical Laser Co., Ltd. | 2019-01-08 |
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| 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 |
| 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 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026-03-31 |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026-03-28 |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | 2026-03-17 |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | 2026-03-17 |
| K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | 2026-03-11 |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-03-06 |
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summary
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