510(k) K211517
- Device
- Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber La
- Applicant
- Convergent Laser Technologies
- 510(k) number
- K211517
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-09
- Date received
- 2021-05-17
- 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
Applicant Contact#
- Contact
- Jennifer Mok
- Address
- 1660 S. Loop Rd. Alameda CA US 94502 94502
FDA Registration Numbers#
- 3008915316
- 3013557562
- 3016405041
- 3023850562
- 1318319
- 3042953831
- 3014226003
- 3027605507
- 3015313684
- 3042641021
- 2031934
- 3019252665
- 3011964664
- 3033905238
- 3010363436
- 3013602304
- 3010314781
- 3011644607
- 3017786046
- 3003015433
- 3015452693
- 3003616071
- 3016453004
- 2953684
- 8040564
- 1000523114
- 3032916575
- 3009746061
- 3015807001
- 3021334828
- 3012980277
- 3023344923
- 3012911444
- 8010720
- 3014388884
- 9614977
- 2134812
- 2032092
- 3013532143
- 3014980461
- 3017060146
- 3003708273
- 3033715699
- 1018470
- 3043140693
- 3032147807
- 3046005941
- 3012125201
- 3010972758
- 3033126947
- 3017200975
- 3025268687
- 3030418454
- 2939653
- 3010027944
- 3015167792
- 3008206114
- 3014225468
- 2529392
- 3025379728
- 3004096429
- 3010273372
- 3012799115
- 3003082988
- 3011743768
- 3038372243
- 3037874486
- 3010707607
- 3011302631
- 3017181358
- 3006580954
- 3007674911
- 3043657394
- 2953696
- 3022327202
- 3043153468
- 3003340844
- 3042228064
- 3027851853
- 3011877721
Source Documents#
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 |