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#
- 3017144492
- 3038356864
- 3016096097
- 3017786046
- 3043153468
- 3007156625
- 1000523114
- 3002806603
- 3012294783
- 3007535734
- 2031934
- 3033126947
- 3019252665
- 2521877
- 1226005
- 3004497289
- 3006985163
- 3003610527
- 3030979014
- 9710340
- 1424785
- 3026400760
- 3004111573
- 3006786907
- 3044175602
- 2032092
- 3016830208
- 3010822033
- 2027755
- 3003288808
- 3011050570
- 3016170453
- 3014577013
- 3005282635
- 3027605646
- 3016413636
- 3042261306
- 3008085016
- 3006580954
- 3010363436
- 2938889
- 3042953831
- 3004361445
- 3002736133
- 3033274371
- 3025861981
- 2938071
- 3040278150
- 3008156177
- 3033273466
- 3004635398
- 3042351542
- 2916735
- 3015976667
- 2953696
- 3043654467
- 3009746061
- 3013503862
- 3021334828
- 3005581016
- 3011423170
- 3005238200
- 8010720
- 3007689716
- 3004069780
- 3043729119
- 3037047060
- 2032112
- 1644312
- 1000393132
- 1064858
- 3010281590
- 3043047259
- 3042255006
- 3008627763
- 3010220595
- 1221275
- 3016496662
- 2247224
Source Documents#
Other 510(k) Records For Product Code GEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262701 | PicoPeak Picosecond Nd:Yag Laser System (Bella-9) | Beijing Sea Heart International Science and Technologyco.Ltd | 2026-10-22 |
| K262628 | Picosecond Laser treatment system (Z180) | Sanhe PERFECTLASER Technology Co., Ltd. | 2026-10-20 |
| 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 |