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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
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 2
ELLIPSE A/S
  SUBSTANTIALLY EQUIVALENT 3
FORMATK SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 3
FOTONA D.O.O.
  SUBSTANTIALLY EQUIVALENT 7
GME GERMAN MEDICAL ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 2
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 4
LUTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 18
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 3522 3522
2019 2708 2708
2020 2178 2178

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 3288 3295
Break 2728 2728
Temperature Problem 2520 2520
Adverse Event Without Identified Device or Use Problem 1619 1619
Appropriate Term/Code Not Available 1328 1328
Detachment of Device or Device Component 868 868
Fiber 755 755
Device Operates Differently Than Expected 667 667
Insufficient Information 404 404
Laser 394 394
Therapeutic or Diagnostic Output Failure 379 379
Tip 375 375
Suction Problem 318 318
Device Displays Incorrect Message 266 266
Overheating of Device 231 231
Device Inoperable 211 211
Connector 198 198
Detachment Of Device Component 197 199
Unexpected Therapeutic Results 195 195
Device Operational Issue 187 187
Crack 176 176
Misfire 156 156
Computer Software Problem 155 155
Defective Device 146 146
Use of Device Problem 128 128
Mechanical Problem 127 127
Decrease in Suction 119 119
Failure to Cut 110 110
Output Problem 102 102
Material Deformation 102 102
Degraded 99 99
Thermal Decomposition of Device 91 91
Material Integrity Problem 89 89
Failure to Fire 72 72
Failure to Deliver Energy 72 72
Improper or Incorrect Procedure or Method 68 68
Suction Failure 68 68
Device Damaged Prior to Use 65 65
Material Fragmentation 65 65
No Apparent Adverse Event 64 64
Melted 60 60
Electrical /Electronic Property Problem 58 58
Handpiece 56 56
Connection Problem 52 52
Material Separation 50 50
Optical Problem 49 49
Energy Output Problem 48 48
Catheter 45 45
Inflation Problem 42 42
Incorrect, Inadequate or Imprecise Resultor Readings 41 41
Insufficient Heating 41 41
Smoking 40 40
Device Or Device Fragments Location Unknown 40 40
Optical Fiber 39 39
No Display/Image 38 38
Charred 36 36
Protective Measures Problem 36 36
Fiberoptic 36 36
Defective Component 35 35
Inadequacy of Device Shape and/or Size 35 35
Gas Leak 35 35
Material Perforation 34 34
Foot Switch 34 34
Probe 33 33
Leak/Splash 33 33
No Device Output 30 30
Patient-Device Incompatibility 27 27
Noise, Audible 27 27
Calibration Problem 26 26
Failure to Power Up 25 25
Loss of Power 24 24
Power Problem 24 24
Infusion or Flow Problem 23 23
Cable, Electrical 22 22
Bent 20 20
Fire 20 20
Unexpected/Unintended Radiation Output 20 20
Output below Specifications 20 20
Loose or Intermittent Connection 19 19
Display or Visual Feedback Problem 19 19
Unexpected Shutdown 18 18
Device Component Or Accessory 17 17
Device Emits Odor 17 17
Device Issue 16 16
Physical Resistance/Sticking 16 16
Pressure Problem 16 16
Positioning Problem 15 15
Failure of Device to Self-Test 15 15
Device Dislodged or Dislocated 15 15
Use of Incorrect Control Settings 15 15
Air Leak 15 15
Power Supply 15 15
Device Handling Problem 15 15
Sparking 14 14
Device Stops Intermittently 14 14
Tear, Rip or Hole in Device Packaging 13 13
Foot Pedal 13 13
Fluid Leak 13 13
Material Twisted/Bent 13 13
Difficult to Remove 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5704 5713
No Consequences Or Impact To Patient 5042 5042
Burn(s) 453 453
Keratitis 408 408
No Code Available 378 379
Visual Impairment 202 202
No Clinical Signs, Symptoms or Conditions 185 185
No Patient Involvement 179 179
No Information 136 136
Pain 119 120
Patient Problem/Medical Problem 109 109
Tissue Damage 106 106
Iatrogenic Source 78 78
Device Embedded In Tissue or Plaque 77 77
Blurred Vision 68 68
Partial thickness (Second Degree) Burn 67 67
Visual Disturbances 66 66
Hemorrhage/Bleeding 64 64
Radiation Exposure, Unintended 61 61
Neurological Deficit/Dysfunction 59 59
Superficial (First Degree) Burn 58 58
Eye Injury 57 57
Edema 57 57
Insufficient Information 54 54
Headache 51 51
Corneal Clouding/Hazing 50 50
Seizures 49 49
Foreign Body In Patient 46 46
Burn, Thermal 44 44
Memory Loss/Impairment 44 44
Complaint, Ill-Defined 41 41
Scarring 41 41
Swelling 38 38
Cognitive Changes 37 37
Weakness 36 36
Injury 35 35
Urinary Tract Infection 34 34
Death 33 33
Skin Discoloration 33 33
Burning Sensation 30 30
Urinary Retention 28 28
Discomfort 28 28
Scar Tissue 25 25
Unspecified Infection 25 25
Paresis 25 25
Hematuria 25 25
Muscle Weakness 24 24
Intracranial Hemorrhage 24 24
Dry Eye(s) 22 22
Incontinence 21 21
Nerve Damage 20 20
Inflammation 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Corneal Edema 19 19
Irritation 18 18
Perforation 18 18
Thrombosis 18 18
Blood Loss 18 18
Full thickness (Third Degree) Burn 18 18
Halo 17 17
Loss of Vision 17 17
Thrombus 17 17
Erythema 15 15
Hematoma 14 14
Dysuria 14 14
Hydrocephalus 14 14
Reaction 12 12
Therapeutic Effects, Unexpected 12 12
Increased Sensitivity 12 12
Fever 11 11
Stenosis 11 11
Therapeutic Response, Decreased 10 10
Itching Sensation 9 9
Bruise/Contusion 9 9
Skin Irritation 9 9
Urinary Frequency 9 9
Numbness 9 9
Nausea 8 8
Vomiting 8 8
Brain Injury 8 8
Impaired Healing 7 7
Foreign Body Sensation in Eye 7 7
Corneal Perforation 7 7
Abrasion 6 6
Radiation Burn 6 6
Sepsis 6 6
Hypersensitivity/Allergic reaction 6 6
Fistula 6 6
Paralysis 6 6
Depression 6 6
Corneal Infiltrates 6 6
Missing Value Reason 6 6
Anxiety 5 5
Post Operative Wound Infection 5 5
Dysphasia 5 5
Cardiac Arrest 5 5
Pulmonary Embolism 5 5
Hemorrhage, Cerebral 5 5
Ambulation Difficulties 5 5
Toxicity 4 4

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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