Powered Laser Surgical Instrument

Device Code: 5654

Product Code(s): GEX

Definition: "a Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General

Device Classification Information

Device Type ID5654
Device NamePowered Laser Surgical Instrument
Regulation DescriptionLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number878.4810 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGEX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5654
DevicePowered Laser Surgical Instrument
Product CodeGEX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.
CFR Regulation Number878.4810 [🔎]
Premarket Reviews
ManufacturerDecision
A.R.C. LASER GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
ABBOTT MEDICAL OPTICS INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ADVALIGHT APS
 
SUBSTANTIALLY EQUIVALENT
 1
ADVANCED MEDICAL OPTICS
 
SUBSTANTIALLY EQUIVALENT
 1
ADVANCED TECHNOLOGY LASER CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
ALCON
 
SUBSTANTIALLY EQUIVALENT
 1
ALCON RESEARCH, LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
ALLMED SYSTEMS INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ALMA LASERS INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ALMA LASERS LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
ALMA LTD
 
SUBSTANTIALLY EQUIVALENT
 1
AMA NETWORK INC
 
SUBSTANTIALLY EQUIVALENT
 1
AMBICARE HEALTH LTD
 
SUBSTANTIALLY EQUIVALENT
 1
AMD GROUP LLC
 
SUBSTANTIALLY EQUIVALENT
 1
AMERICAN MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
AMERICAN MEDICAL SYSTEMS
 
SUBSTANTIALLY EQUIVALENT
 1
ANGIODYNAMICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
ASCLEPION LASER TECHNOLOGIES GMBH
 
SUBSTANTIALLY EQUIVALENT
 8
BEIJING ANCHORFREE TECHNOLOGY CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
BEIJING HONKON TECHNOLOGIES CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 3
Beijing Toplaser Technology Co., Ltd.
 
SUBSTANTIALLY EQUIVALENT
 3
BIOLASE, INC
 
SUBSTANTIALLY EQUIVALENT
 2
BIOLASE, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
BIO-MED
 
SUBSTANTIALLY EQUIVALENT
 1
BIO-MED U.S.A., INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BIO-MED USA INC
 
SUBSTANTIALLY EQUIVALENT
 1
BIO-MED USA INC.
 
SUBSTANTIALLY EQUIVALENT
 2
BIOS S.R.L.
 
SUBSTANTIALLY EQUIVALENT
 1
BISON MEDICAL CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 2
BOSTON SCIENTIFIC
 
SUBSTANTIALLY EQUIVALENT
 1
BOSTON SCIENTIFIC CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
CANDELA
 
SUBSTANTIALLY EQUIVALENT
 4
CANDELA CORP.
 
SUBSTANTIALLY EQUIVALENT
 4
CANDELA CORPATION
 
SUBSTANTIALLY EQUIVALENT
 1
CAO GROUP, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
CLINICAL LASERTHERMIA SYSTEMS AB
 
SUBSTANTIALLY EQUIVALENT
 3
COLOPLAST CORP
 
SUBSTANTIALLY EQUIVALENT
 1
COLOPLAST MANUFACTURING US LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CONVERGENT DENTAL, INC
 
SUBSTANTIALLY EQUIVALENT
 1
COOK, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
CUTERA, INC.
 
SUBSTANTIALLY EQUIVALENT
 7
CYDEN LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
CYNOSURE, INC.
 
SUBSTANTIALLY EQUIVALENT
 7
CYNOSURE, INC. DBA ELLMAN
 
SUBSTANTIALLY EQUIVALENT
 1
DIOTECH CO
 
SUBSTANTIALLY EQUIVALENT
 2
DORNIER MEDTECH
 
SUBSTANTIALLY EQUIVALENT
 3
DORNIER MEDTECH AMERICA, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
DR. WOLFGANG NEUBERGER
 
SUBSTANTIALLY EQUIVALENT
 1
EL.EN. ELECTRONIC ENGINEERING SPA
 
SUBSTANTIALLY EQUIVALENT
 2
EL.EN. S.P.A
 
SUBSTANTIALLY EQUIVALENT
 1
ELLIPSE A/S
 
SUBSTANTIALLY EQUIVALENT
 3
EQUIPMED NORTH AMERICA, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
FOCUS MEDICAL, LLC.
 
SUBSTANTIALLY EQUIVALENT
 1
FORMATK SYSTEMS LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
FOTONA D.D.
 
SUBSTANTIALLY EQUIVALENT
 2
FOTONA D.O.O.
 
SUBSTANTIALLY EQUIVALENT
 3
G.N.S NEOLASER LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
GLOBAL USA DISTRIBUTION, LLC
 
SUBSTANTIALLY EQUIVALENT
 3
GME (GERMAN MEDICAL ENGINEERING) GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
GME GERMAN MEDICAL ENGINEERING GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
HOGAN LOVELLS US, L.L.P.
 
SUBSTANTIALLY EQUIVALENT
 1
HOGUE SURGICAL LLC
 
SUBSTANTIALLY EQUIVALENT
 1
INMODE MD LTD.
 
SUBSTANTIALLY EQUIVALENT
 4
INNOVAQUARTZ LLC
 
SUBSTANTIALLY EQUIVALENT
 2
IRIDEX CORP.
 
SUBSTANTIALLY EQUIVALENT
 4
IRIDEX CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 4
JEISYS MEDICAL INC.
 
SUBSTANTIALLY EQUIVALENT
 1
KARL STORZ GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 1
KARL STORZ SE & CO KG
 
SUBSTANTIALLY EQUIVALENT
 1
LASER ENGINEERING, INC
 
SUBSTANTIALLY EQUIVALENT
 1
LASER PERIPHERALS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
LASEROPTEK CO. LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
LIGHT SCALPEL LLC
 
SUBSTANTIALLY EQUIVALENT
 1
LIGHTSCALPEL LLC
 
SUBSTANTIALLY EQUIVALENT
 2
LITECURE, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
LUMENIS LTD
 
SUBSTANTIALLY EQUIVALENT
 5
LUMENIS LTD.
 
SUBSTANTIALLY EQUIVALENT
 6
LUMENIS, INC.
 
SUBSTANTIALLY EQUIVALENT
 11
LUTRONIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 4
LUTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
MERIDIAN AG
 
SUBSTANTIALLY EQUIVALENT
 1
MERIDIAN CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
MILLENNIUM DENTAL TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MONTERIS MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 3
MONTERIS MEDICAL CORP
 
SUBSTANTIALLY EQUIVALENT
 1
MONTERIS MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
NEW STAR LASERS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
NOVIAN HEALTH, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
OBERON GMBH FIBER TECHNOLOGIES
 
SUBSTANTIALLY EQUIVALENT
 1
OD -OS GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
OD-OS GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
OMNIGUIDE, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
PATIENT POCKET, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
PATIENT POCKET, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
PRECISE LIGHT SURGICAL
 
SUBSTANTIALLY EQUIVALENT
 1
QUANTA SYSTEM S.P.A.
 
SUBSTANTIALLY EQUIVALENT
 5
QUANTA SYSTEM SPA
 
SUBSTANTIALLY EQUIVALENT
 16
QUANTA SYSTEM, S.P.A.
 
SUBSTANTIALLY EQUIVALENT
 2
REGULATORY TECHNOLOGY SERVICES, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
ROGERS SCIENCES INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SCARLET RF, INC
 
SUBSTANTIALLY EQUIVALENT
 1
SCITON, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SHANGHAI WONDERFUL OPTELECTRICS TECH. CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SHARPLIGHT TECHNOLOGIES LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SHASER, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SHEAUMANN LASER, INC
 
SUBSTANTIALLY EQUIVALENT
 1
SHENZHEN GSD TECH. CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
STRATA SKIN SCIENCES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SYNERON
 
SUBSTANTIALLY EQUIVALENT
 1
SYNERON MEDICAL LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS)
 
SUBSTANTIALLY EQUIVALENT
 1
VENUS CONCEPT LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
VIAX DENTAL LAB
 
SUBSTANTIALLY EQUIVALENT
 1
VIORA LTD.
 
SUBSTANTIALLY EQUIVALENT
 4
VITAGE LED LTD
 
SUBSTANTIALLY EQUIVALENT
 1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
 
SUBSTANTIALLY EQUIVALENT
 2
WARD PHOTONICS LLC
 
SUBSTANTIALLY EQUIVALENT
 1
WON TECH
 
SUBSTANTIALLY EQUIVALENT
 2
YERIM ENGINEERING CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
ZOLAR TECHNOLOGY & MFG CO. INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Fracture
 3432
Temperature Problem
 3280
Break
 1673
Appropriate Term/Code Not Available
 1047
Adverse Event Without Identified Device Or Use Problem
 806
Detachment Of Device Or Device Component
 763
Fiber
 669
Tip
 327
Device Operates Differently Than Expected
 311
Device Inoperable
 255
Connector
 215
Device Displays Incorrect Message
211
Detachment Of Device Component
 175
Unexpected Therapeutic Results
158
Crack
 157
Overheating Of Device
 143
Device Operational Issue
 142
Insufficient Information
 111
Laser
 106
Misfire
97
Material Deformation
 93
Thermal Decomposition Of Device
 82
Use Of Device Problem
 68
Material Integrity Problem
 67
Device Damaged Prior To Use
61
Charred
 58
Catheter
 58
Material Fragmentation
 49
Material Perforation
 46
Computer Software Problem
 45
Device Or Device Fragments Location Unknown
 44
Melted
 42
No Display / Image
 41
Handpiece
 40
Material Separation
 39
System
 39
Improper Or Incorrect Procedure Or Method
 34
Inflation Problem
 33
Fiberoptic
 30
Output Problem
 28
Electrical /Electronic Property Problem
 27
Energy Output Problem
26
Mechanical Problem
 26
Interface
 25
Foot Switch
 25
Connection Problem
 25
No Apparent Adverse Event
 25
Degraded
 23
Decrease In Suction
 23
Calibration Problem
 23
Leak / Splash
 23
Failure To Deliver Energy
21
Probe
 21
Device Issue
 20
Bent
 20
Failure To Fire
20
Smoking
 19
Optical Problem
 19
Insufficient Heating
 17
Suction Problem
 15
Imprecision
15
Optical Fiber
 13
Loss Of Or Failure To Bond
 13
Power Supply
 13
Power Problem
 13
Cable
 13
Output Below Specifications
 12
Failure To Power Up
 12
Loss Of Power
 11
Foot Pedal
 11
Communication Or Transmission Problem
 11
Flare Or Flash
 11
Device Stops Intermittently
 10
Loose Or Intermittent Connection
 10
Fluid Leak
 9
Noise, Audible
 9
Device Handling Problem
 9
Human Factors Issue
 9
Device Component Or Accessory
 9
Fire
 9
Energy Output To Patient Tissue Incorrect
 7
Hole In Material
 7
Unintended Movement
 7
Defective Device
 7
No Device Output
6
Display Or Visual Feedback Problem
 6
Failure To Align
 6
Use Of Incorrect Control Settings
 6
Difficult To Remove
6
Sparking
 6
Physical Property Issue
 6
Maintenance Does Not Comply To Manufacturers Recommendations
 6
Component Missing
5
Failure To Calibrate
 5
Circuit Failure
 5
Application Interface Becomes Non-Functional Or Program Exits Abnormally
 5
Junction
 5
Device Damaged By Another Device
 5
Device Packaging Compromised
 5
Peeled / Delaminated
 5
Total Device Problems 15856
Recalls
Manufacturer Recall Class Date Posted
1
American Medical Systems Innovation Center - Silicon Valley
 II Jul-21-2015
2
Beijing Syntech Laser Co., Ltd
 II May-02-2018
3
Biolase Technology Inc
 II Aug-18-2014
4
Boston Scientific Corporation
 II Mar-05-2018
5
Boston Scientific Corporation
 II Oct-08-2014
6
Cook Inc.
 II Jun-14-2017
7
Cook Inc.
 II Jun-05-2017
8
Cynosure, Inc.
 II Nov-04-2014
9
Ellipse A/S
 II Jun-09-2016
10
Iridex Corporation
 II Mar-16-2018
11
Laser Peripherals LLC
 II Jul-17-2014
12
Laserex Systems Inc.
 II Jun-06-2017
13
Leoni Fiber Optics GmbH
 II Dec-07-2018
14
Lumenis Limited
 II Oct-23-2016
15
Lumenis Limited
 II Apr-24-2015
16
Lumenis Ltd
 II May-13-2016
17
Medtronic Navigation, Inc.
 II Jul-19-2018
18
Medtronic Navigation, Inc.
 II Oct-18-2017
19
Medtronic Navigation, Inc.
 II Jul-03-2017
20
Medtronic Navigation, Inc.
 II May-16-2016
21
Monteris Medical Corp
 I Mar-20-2018
22
Monteris Medical Corp
 I May-16-2016
23
Monteris Medical Corp
 II Nov-19-2014
24
New Star Lasers, Inc.
 II Sep-30-2016
25
New Star Lasers, Inc.
 II Jun-27-2015
26
Nidek Inc
 II Jul-14-2015
27
Nidek Inc
 II Aug-13-2014
28
Ra Medical Systems Inc
 II Jul-28-2014
29
Strata Skin Sciences, Inc.
 II Mar-27-2017
30
Xintec Corp
 II Aug-02-2017
TPLC Last Update: 2019-04-02 21:10:17
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