510(k) K050738
- Device
- FT FIBER OPTIC DELIVERY SYSTEMS
- Applicant
- FIBERTECH GMBH
- 510(k) number
- K050738
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-06-02
- Date received
- 2005-03-17
- 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
- ARMIN KAUS
- Address
- 4111 E. Valley Auto Dr. Suite 104 Mesa AZ US 85206 85206
FDA Registration Numbers#
- 3043657394
- 3012322232
- 3010912900
- 3006849754
- 1319639
- 3010314781
- 3013446079
- 3040278125
- 1000121056
- 3014253920
- 3011024620
- 3003340844
- 2936921
- 1216677
- 3007549439
- 3010724743
- 2939653
- 3005580113
- 3005801723
- 3005987567
- 1644312
- 3010027944
- 3008085016
- 3034995492
- 3043153468
- 3042255006
- 8043564
- 3004483538
- 2125050
- 3014132468
- 3043127589
- 3006617841
- 3043012240
- 3030233762
- 2938889
- 3029897009
- 3033715699
- 3034246188
- 3016170453
- 3005205318
- 3015907115
- 3005515469
- 3005855240
- 3017125161
- 3015807001
- 3010822033
- 3026038437
- 3004633032
- 3030230686
- 3020900954
- 3007156625
- 3009078366
- 3017200975
- 3015730775
- 3023344928
- 3021315370
- 3003683459
- 3005739661
- 3016496662
- 3010902869
- 2031934
- 3007712511
- 3021550489
- 3012799115
- 3043846025
- 1226486
- 3018318562
- 3030979156
- 2032092
- 3025861981
- 3006427656
- 3033844600
- 3009488834
- 3013619029
- 3044995573
- 3010707607
- 2183744
- 3008720474
- 1032227
Source Documents#
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#
summary
FDA Review#
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