Panels › General, Plastic Surgery › Product code GEX · Class 2
Powered Laser Surgical Instrument
Regulation 878.4810
71510(k)s in 12 months (2,892 all time)
6recalls in 12 months (201 all time)
150recalls that name a 510(k)
Top companies in GEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cynosure, Inc. | 84 | 1 |
| Lumenis | 60 | 11 |
| Sharplan Lasers, Inc. | 66 | 0 |
| Quanta System Spa | 57 | 6 |
| Candela Corp. | 53 | 5 |
| Laserscope | 49 | 0 |
| Trimedyne, Inc. | 48 | 0 |
| Heraeus Lasersonics, Inc. | 37 | 0 |
| Surgical Laser Technologies, Inc. | 35 | 0 |
| Boston Scientific | 11 | 23 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2016 | Ellipse A/S Ellipse ND: YAG Laser applicator for Ellipse Multiflex
Medical Laser Products. Terminated |
GEX | K140670 |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Stripper, 0.2mm Disposable EndoStat Fiber,
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Stripper, 0.3mm Disposable EndoStat Fiber,
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Stripper, 0.4mm Disposable EndoStat Fiber,
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Stripper, 0.6mm Disposable EndoStat Fiber,
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 28S, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 28S, Nonautoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 44S, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 44S, Nonautoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 18S, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 18S, Nonautoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 14S, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 14S, Nonautoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 12S, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, Stripper W/BLD, 12S, Nonautoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, StripperW/BLD, 10S, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Tool, StripperW/BLD, 10S, Nonautoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley 1X1 Cleaving Tiles;
The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Fiber Cleaver;
Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP)
The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Fiber Stripper, 910m, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to dire Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Fiber Stripper, 550m, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to dire Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Fiber Stripper, 365m, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to dire Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Fiber Stripper, 273m, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to dire Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Fiber Stripper, 200m, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to dire Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Fiber Stripper, 150m, Autoclavable;
The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to dire Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley 365M Lithotripsy Fiber- Reusable;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures Terminated |
GEX | K140679 |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley 200M Lithotripsy Fiber- Reusable;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures Terminated |
GEX | K140679 |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 910 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | K050108 |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 550 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | K050108 |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 365 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | K050108 |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 273 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | K050108 |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 200 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | K050108 |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 150 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | K050108 |
| Jul 14, 2015 | Nidek Inc Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System;
GYC4EP-01 0W02 and GYC4EP-1 0Z20;
The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in oph Terminated |
GEX | K032085 K133358 |
| Jul 14, 2015 | Nidek Inc Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system
GYC4DD-1:
The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including re Terminated |
GEX | K032085 K133358 |
| Jun 27, 2015 | New Star Lasers, Inc. StoneLight 30 Laser System (NS3000).
For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft t Terminated |
GEX | K142286 |
| Apr 24, 2015 | Lumenis Limited Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. Terminated |
GEX | K003614 |
| Nov 19, 2014 | Monteris Medical Corp FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devi Terminated |
GEX | K131278 K131955 +1 |
| Nov 19, 2014 | Monteris Medical Corp SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser device Terminated |
GEX | K120561 K131955 +1 |
| Nov 4, 2014 | Cynosure, Inc. Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System Terminated |
GEX | K091169 |
| Oct 8, 2014 | Boston Scientific Corporation StarMedTec LightTrail Reusable Fibers, 800 um; Material/Part Number: 6457 Terminated |
GEX | K111475 |
| Oct 8, 2014 | Boston Scientific Corporation StarMedTec LightTrail Reusable Fibers, 600 um; Material/Part Number: 6455 Terminated |
GEX | K111475 |
| Oct 8, 2014 | Boston Scientific Corporation StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453 Terminated |
GEX | K111475 |
| Aug 18, 2014 | Biolase Technology Inc WaterLase iPlus Dental Laser System, Part No. 7200854-XX
Software Upgrade Kit, Part No. 6201463. Terminated |
GEX | K101658 |
| Aug 13, 2014 | Nidek Inc GYC-1000 Green Laser Photocoagulator system
The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulatio Terminated |
GEX | K032085 |
| Jul 28, 2014 | Ra Medical Systems Inc PHAROS Excimer Laser, Model No. EX-308
UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma Terminated |
GEX | K062963 |
| Jul 17, 2014 | Laser Peripherals LLC LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO.
Laser surgical instrument for use in general and plastic surgery and in dermatology Terminated |
GEX | K030959 |
| Nov 18, 2013 | Candela Corporation Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015.
and Candela Laser GentleLase Pro LE,
Model number: 9914-00-9040 Terminated |
GEX | K024260 K024335 +1 |
| Oct 22, 2013 | Convergent Dental Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology. Terminated |
GEX | K123494 K130420 |
| Oct 1, 2013 | PhotoMedex, Inc. The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***.
The product is packaged in a flexible pouch and in Terminated |
GEX | K082721 |
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