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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device powered laser surgical instrument
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
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 surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
Product CodeGEX
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
A.R.C. LASER GMBH
  SUBSTANTIALLY EQUIVALENT 2
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALMA LASERS INC.
  SUBSTANTIALLY EQUIVALENT 2
ALMA LTD
  SUBSTANTIALLY EQUIVALENT 1
AMA NETWORK INC
  SUBSTANTIALLY EQUIVALENT 1
AMBICARE HEALTH LTD
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 2
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOLASE, INC
  SUBSTANTIALLY EQUIVALENT 3
BIOLASE, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIO-MED USA INC
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED USA INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BISON MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CANDELA
  SUBSTANTIALLY EQUIVALENT 3
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 3
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 5
CLINICAL LASERTHERMIA SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 2
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 5
CYDEN LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DIOTECH CO
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 2
DORNIER MEDTECH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 3
ELLIPSE A/S
  SUBSTANTIALLY EQUIVALENT 3
FORMATK SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 3
FOTONA D.O.O.
  SUBSTANTIALLY EQUIVALENT 8
GME GERMAN MEDICAL ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 3
ILOODA CO LTD
  SUBSTANTIALLY EQUIVALENT 1
INMODE MD LTD.
  SUBSTANTIALLY EQUIVALENT 3
INNOVAQUARTZ LLC
  SUBSTANTIALLY EQUIVALENT 1
IRIDEX CORP.
  SUBSTANTIALLY EQUIVALENT 3
IRIDEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
JEISYS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
LASER PERIPHERALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LASEROPTEK CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTSCALPEL LLC
  SUBSTANTIALLY EQUIVALENT 1
LITECURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS LTD
  SUBSTANTIALLY EQUIVALENT 2
LUMENIS LTD.
  SUBSTANTIALLY EQUIVALENT 7
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 9
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
LUTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
M&T SRL
  SUBSTANTIALLY EQUIVALENT 2
MERIDIAN AG
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MILLENNIUM DENTAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MONTERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MONTERIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVIAN HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
OD-OS GMBH
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
OMNIGUIDE, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 19
QUANTA SYSTEM, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RAJA TRADING COMPANY, INC
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SCITON, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SHANGHAI WONDERFUL OPTELECTRICS TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHARPLIGHT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN GSD TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SILHOUET-TONE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRATA SKIN SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS)
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT LTD.
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT USA INC.
  SUBSTANTIALLY EQUIVALENT 1
VIAX DENTAL LAB
  SUBSTANTIALLY EQUIVALENT 1
VIORA LTD.
  SUBSTANTIALLY EQUIVALENT 2
VITAGE LED LTD
  SUBSTANTIALLY EQUIVALENT 1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 2
WON TECH
  SUBSTANTIALLY EQUIVALENT 5
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

MDR Year MDR Reports MDR Events
2016 2582 2591
2017 2974 2974
2018 3523 3523
2019 2709 2709
2020 2182 2182
2021 1141 1141

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 3359 3366
Break 2869 2869
Temperature Problem 2525 2525
Adverse Event Without Identified Device or Use Problem 1802 1802
Appropriate Term/Code Not Available 1444 1444
Detachment of Device or Device Component 904 904
Device Operates Differently Than Expected 667 667
Decrease in Suction 432 432
Insufficient Information 419 419
Therapeutic or Diagnostic Output Failure 398 398
Suction Problem 326 326
Device Displays Incorrect Message 275 275
Overheating of Device 259 259
Device Operational Issue 211 211
Device Inoperable 211 211
Unexpected Therapeutic Results 198 198
Detachment Of Device Component 197 199
Crack 179 179
Defective Device 162 162
Misfire 157 157
Computer Software Problem 156 156
Mechanical Problem 155 155
Use of Device Problem 139 139
Output Problem 123 123
Degraded 121 121
Failure to Cut 115 115
Material Deformation 105 105
Failure to Fire 96 96
Thermal Decomposition of Device 93 93
Material Integrity Problem 89 89
Suction Failure 86 86
Failure to Deliver Energy 82 82
No Apparent Adverse Event 79 79
Material Fragmentation 69 69
Improper or Incorrect Procedure or Method 68 68
Device Damaged Prior to Use 68 68
Melted 63 63
Electrical /Electronic Property Problem 61 61
Connection Problem 59 59
Material Separation 54 54
Optical Problem 51 51
Energy Output Problem 49 49
Incorrect, Inadequate or Imprecise Resultor Readings 47 47
Inflation Problem 44 44
Insufficient Heating 42 42
Smoking 41 41
Device Or Device Fragments Location Unknown 40 40
No Display/Image 39 39
Charred 36 36
Protective Measures Problem 36 36
Inadequacy of Device Shape and/or Size 36 36
Defective Component 35 35
Gas Leak 35 35
Material Perforation 34 34
Patient-Device Incompatibility 33 33
Leak/Splash 33 33
Power Problem 31 31
No Device Output 31 31
Failure to Align 29 29
Calibration Problem 28 28
Infusion or Flow Problem 28 28
Noise, Audible 28 28
Failure to Power Up 28 28
Output below Specifications 28 28
Display or Visual Feedback Problem 27 27
Loss of Power 24 24
Fire 23 23
Unexpected/Unintended Radiation Output 23 23
Firing Problem 21 21
Bent 20 20
Unexpected Shutdown 19 19
Loose or Intermittent Connection 19 19
Physical Resistance/Sticking 18 18
Device Emits Odor 18 18
Pressure Problem 17 17
Peeled/Delaminated 17 17
Device Issue 16 16
Device Handling Problem 16 16
Device Dislodged or Dislocated 15 15
Air Leak 15 15
Use of Incorrect Control Settings 15 15
Positioning Problem 15 15
Failure of Device to Self-Test 15 15
Device Stops Intermittently 14 14
Fluid Leak 14 14
Sparking 14 14
Material Twisted/Bent 13 13
Tear, Rip or Hole in Device Packaging 13 13
Flare or Flash 12 12
Loss of or Failure to Bond 12 12
Difficult to Remove 12 12
Hole In Material 11 11
Unsealed Device Packaging 11 11
Material Puncture/Hole 11 11
Burst Container or Vessel 11 11
Human Factors Issue 11 11
Activation Problem 11 11
Human-Device Interface Problem 10 10
Computer Operating System Problem 10 10
Excessive Heating 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5719 5728
No Consequences Or Impact To Patient 5096 5096
No Clinical Signs, Symptoms or Conditions 963 963
Burn(s) 468 468
Keratitis 449 449
No Code Available 378 379
Visual Impairment 231 231
No Patient Involvement 180 180
Insufficient Information 165 165
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 142 142
No Information 140 140
Pain 132 133
Blurred Vision 122 122
Patient Problem/Medical Problem 109 109
Tissue Damage 106 106
Visual Disturbances 94 94
Device Embedded In Tissue or Plaque 79 79
Radiation Exposure, Unintended 78 78
Iatrogenic Source 78 78
Eye Injury 69 69
Partial thickness (Second Degree) Burn 68 68
Hemorrhage/Bleeding 67 67
Superficial (First Degree) Burn 59 59
Neurological Deficit/Dysfunction 59 59
Edema 57 57
Headache 53 53
Corneal Clouding/Hazing 52 52
Seizures 49 49
Foreign Body In Patient 48 48
Burn, Thermal 45 45
Memory Loss/Impairment 45 45
Scarring 42 42
Complaint, Ill-Defined 41 41
Swelling 39 39
Cognitive Changes 37 37
Weakness 36 36
Burning Sensation 35 35
Injury 35 35
Discomfort 35 35
Urinary Tract Infection 34 34
Skin Discoloration 34 34
Death 33 33
Inflammation 31 31
Dry Eye(s) 29 29
Urinary Retention 29 29
Scar Tissue 27 27
Muscle Weakness 27 27
Paresis 26 26
Unspecified Infection 26 26
Intracranial Hemorrhage 25 25
Hematuria 25 25
Nerve Damage 23 23
Halo 23 23
Incontinence 22 22
Corneal Abrasion 21 21
Corneal Edema 20 20
Erythema 19 19
Perforation 19 19
Thrombosis 18 18
Irritation 18 18
Loss of Vision 18 18
Foreign Body Sensation in Eye 18 18
Blood Loss 18 18
Full thickness (Third Degree) Burn 18 18
Thrombus 17 17
Eye Pain 16 16
Hydrocephalus 14 14
Hematoma 14 14
Dysuria 14 14
Red Eye(s) 13 13
Reaction 12 12
Therapeutic Effects, Unexpected 12 12
Increased Sensitivity 12 12
Fever 11 11
Stenosis 11 11
Therapeutic Response, Decreased 10 10
Bruise/Contusion 10 10
Skin Irritation 10 10
Eye Infections 10 10
Urinary Frequency 9 9
Numbness 9 9
Itching Sensation 9 9
Nausea 8 8
Vomiting 8 8
Brain Injury 8 8
Corneal Perforation 8 8
Hypersensitivity/Allergic reaction 7 7
Corneal Infiltrates 7 7
Impaired Healing 7 7
Depression 6 6
Dysphasia 6 6
Missing Value Reason 6 6
Swelling/ Edema 6 6
Paralysis 6 6
Fistula 6 6
Sepsis 6 6
Abrasion 6 6
Radiation Burn 6 6
Vessel Or Plaque, Device Embedded In 5 5
Pulmonary Embolism 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Aerolase Corporation II Jan-03-2020
2 Angiodynamics, Inc. II Aug-30-2019
3 Beijing Syntech Laser Co., Ltd II May-02-2018
4 Boston Scientific Corporation II Apr-24-2020
5 Boston Scientific Corporation II May-22-2019
6 Boston Scientific Corporation II Mar-05-2018
7 Candela Corporation II Oct-24-2019
8 Cook Inc. II Jun-14-2017
9 Cook Inc. II Jun-05-2017
10 Dornier Medtech America, Inc. II May-21-2019
11 Ellipse A/S II Jun-09-2016
12 Inova Lasers LLC II Nov-17-2020
13 Iridex Corporation II Mar-16-2018
14 Laserex Systems Inc. II Jun-06-2017
15 Leoni Fiber Optics GmbH II Dec-07-2018
16 Lumenis Limited II Oct-23-2016
17 Lumenis Ltd II May-13-2016
18 Medtronic Navigation, Inc. II May-06-2020
19 Medtronic Navigation, Inc. II Jul-19-2018
20 Medtronic Navigation, Inc. II Oct-18-2017
21 Medtronic Navigation, Inc. II Jul-03-2017
22 Medtronic Navigation, Inc. II May-16-2016
23 Medtronic Sofamor Danek USA Inc II Jul-23-2020
24 Monteris Medical Corp I Mar-20-2018
25 Monteris Medical Corp I May-16-2016
26 New Star Lasers, Inc. II Sep-30-2016
27 Ra Medical Systems, Inc. II Apr-01-2020
28 Strata Skin Sciences, Inc. II Mar-27-2017
29 Xintec Corp III Oct-18-2019
30 Xintec Corp II Aug-02-2017
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