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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
ACTIVE OPTICAL SYSTEMS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
AESTHETIC TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALMA LASERS INC.
  SUBSTANTIALLY EQUIVALENT 2
ALMA LASERS LTD
  SUBSTANTIALLY EQUIVALENT 1
ALMA LASERS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALMA LTD
  SUBSTANTIALLY EQUIVALENT 1
AMA NETWORK INC
  SUBSTANTIALLY EQUIVALENT 1
AMBICARE HEALTH LTD
  SUBSTANTIALLY EQUIVALENT 1
AMI INC.
  SUBSTANTIALLY EQUIVALENT 2
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 2
AVENDA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
AZENA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BEIJING ADSS DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
BEIJING HUACHENG TAIKE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING LEAD BEAUTY S & T CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
BEIJING SANO LASER S&T DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING SUPERLASER TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BIO-MED USA INC
  SUBSTANTIALLY EQUIVALENT 2
BIO-MED USA INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOLASE, INC
  SUBSTANTIALLY EQUIVALENT 3
BIOLASE, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOS S.R.L
  SUBSTANTIALLY EQUIVALENT 1
BIOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BISON MEDICAL CO LTD
  SUBSTANTIALLY EQUIVALENT 1
BISON MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BLUECORE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
C.I.S LTD
  SUBSTANTIALLY EQUIVALENT 1
CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 5
CERAMOPTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL LASERTHERMIA SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 2
CLINICAL LASERTHERMIA SYSTEMS, AB
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 5
CYDEN LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE LLC
  SUBSTANTIALLY EQUIVALENT 2
CYNOSURE, INC
  SUBSTANTIALLY EQUIVALENT 2
DAEJU MEDITECH ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DIOTECH CO
  SUBSTANTIALLY EQUIVALENT 1
DOMINION AESTHETIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
EL. EN ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
EL..EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
EL.EN ELECTRONIC ENGINEERING S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
EL.EN ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 4
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 3
ELEMENIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELEN ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE A/S
  SUBSTANTIALLY EQUIVALENT 3
EPILADY 2000 LLC
  SUBSTANTIALLY EQUIVALENT 1
FINEMEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOCUS MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
FOCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
FORMATK SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 3
FOTONA D.O.O.
  SUBSTANTIALLY EQUIVALENT 9
GLOBAL MED SYSTEMS SL
  SUBSTANTIALLY EQUIVALENT 1
GME GERMAN MEDICAL ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 3
GUANGZHOU HUAFEI TONGDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HIGH TECHNOLOGY PRODUCTS SLU
  SUBSTANTIALLY EQUIVALENT 3
HIRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HULASER, INC.
  SUBSTANTIALLY EQUIVALENT 1
HYPER PHOTONICS SRL
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GROUP S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
IDS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO LTD
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INMODE MD LTD.
  SUBSTANTIALLY EQUIVALENT 3
INNOVAQUARTZ LLC
  SUBSTANTIALLY EQUIVALENT 2
INTELLIGENT SENSORY CONCEPT SA
  SUBSTANTIALLY EQUIVALENT 1
IRIDEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
JEISYS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
LAMEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LASER PERIPHERALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LASEROPTEK CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
LASEROPTEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
LASEROPTEK CO.LTD
  SUBSTANTIALLY EQUIVALENT 1
LAZON MEDICAL LASER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEONI FIBER OPTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED DENTALTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTSCALPEL LLC
  SUBSTANTIALLY EQUIVALENT 1
LITECURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS LTD
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS LTD.
  SUBSTANTIALLY EQUIVALENT 7
LUMENIS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
LUTRONIC GLOBAL
  SUBSTANTIALLY EQUIVALENT 1
LUVO MEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
M&T S.R.L
  SUBSTANTIALLY EQUIVALENT 1
M&T SRL
  SUBSTANTIALLY EQUIVALENT 2
MEDICO USA INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDKEY, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN AG
  SUBSTANTIALLY EQUIVALENT 1
MILLENNIUM DENTAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MONTERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MONTERIS MEDICAL,
  SUBSTANTIALLY EQUIVALENT 1
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 1
OMNIGUIDE, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
QUANTA SYSTEM, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RAJA TRADING COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1
REALTON (SUZHOU) MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
REALTON (SUZHOU) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
REVEALLUX, CORP
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
SAN HE LEFIS ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCITON, INC
  SUBSTANTIALLY EQUIVALENT 2
SCITON, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HUAMEI TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
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
SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SILHOUET-TONE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SOLITON INC.
  SUBSTANTIALLY EQUIVALENT 4
STEP UP SKIN LASER, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRATA SKIN SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL LASER INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
SYNERON CANDELA CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
SYNERON-CANDELA
  SUBSTANTIALLY EQUIVALENT 1
SYNERON-CANDELA CORP
  SUBSTANTIALLY EQUIVALENT 1
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS)
  SUBSTANTIALLY EQUIVALENT 1
U.S. LASER WORX
  SUBSTANTIALLY EQUIVALENT 1
UVBIOTEK, LLC
  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
  SUBSTANTIALLY EQUIVALENT 1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 2
W & R INVESTMENTS, LLC DBA LASER ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
WEIFANG KM ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WEIFANG MINGLIANG ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WINGDERM ELECTRO-OPTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
WON TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
WONTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
YERIM ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHENGZHOU BESTVIEW ST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHUOLU JONTELASER MANUFACTURING 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 2667 2667

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 3378 3385
Break 3055 3055
Temperature Problem 2531 2531
Adverse Event Without Identified Device or Use Problem 2059 2059
Appropriate Term/Code Not Available 1481 1481
Detachment of Device or Device Component 921 921
Decrease in Suction 887 887
Device Operates Differently Than Expected 667 667
Insufficient Information 442 442
Therapeutic or Diagnostic Output Failure 415 415
Suction Problem 331 331
Device Displays Incorrect Message 300 300
Overheating of Device 281 281
Device Operational Issue 237 237
Device Inoperable 211 211
Defective Device 204 204
Unexpected Therapeutic Results 199 199
Detachment Of Device Component 197 199
Output Problem 187 187
Crack 183 183
Mechanical Problem 180 180
Degraded 169 169
Misfire 160 160
Computer Software Problem 156 156
Use of Device Problem 156 156
Failure to Fire 126 126
Failure to Cut 115 115
Material Deformation 107 107
Thermal Decomposition of Device 103 103
Failure to Deliver Energy 102 102
Material Integrity Problem 96 96
Suction Failure 94 94
No Apparent Adverse Event 88 88
Firing Problem 83 83
Connection Problem 82 82
Failure to Align 75 75
Material Fragmentation 74 74
Optical Problem 71 71
Improper or Incorrect Procedure or Method 71 71
Device Damaged Prior to Use 68 68
Electrical /Electronic Property Problem 68 68
Melted 67 67
Material Separation 59 59
Power Problem 58 58
Device Contaminated During Manufacture or Shipping 58 58
Incorrect, Inadequate or Imprecise Resultor Readings 55 55
Energy Output Problem 51 51
Inflation Problem 50 50
Insufficient Heating 49 49
No Device Output 45 45
Smoking 44 44
No Display/Image 40 40
Device Or Device Fragments Location Unknown 40 40
Failure to Power Up 39 39
Defective Component 39 39
Inadequacy of Device Shape and/or Size 36 36
Charred 36 36
Protective Measures Problem 36 36
Infusion or Flow Problem 36 36
Gas Leak 35 35
Patient-Device Incompatibility 34 34
Material Perforation 34 34
Noise, Audible 33 33
Leak/Splash 33 33
Output below Specifications 31 31
Unexpected/Unintended Radiation Output 31 31
Display or Visual Feedback Problem 31 31
Calibration Problem 29 29
Fire 28 28
Gas Output Problem 27 27
Loss of Power 26 26
Loss of or Failure to Bond 23 23
Unexpected Shutdown 23 23
Physical Resistance/Sticking 22 22
Loose or Intermittent Connection 20 20
Bent 20 20
Device Emits Odor 20 20
Peeled/Delaminated 19 19
Pressure Problem 17 17
Device Issue 16 16
Device Handling Problem 16 16
Sparking 15 15
Device Dislodged or Dislocated 15 15
Material Twisted/Bent 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
Tear, Rip or Hole in Device Packaging 14 14
Device Stops Intermittently 14 14
Fluid Leak 14 14
Flare or Flash 13 13
Material Puncture/Hole 12 12
Difficult to Remove 12 12
Unsealed Device Packaging 12 12
Hole In Material 11 11
Burst Container or Vessel 11 11
Human Factors Issue 11 11
Activation Problem 11 11
Human-Device Interface Problem 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 2104 2104
Burn(s) 485 485
Keratitis 485 485
No Code Available 378 379
Insufficient Information 275 275
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 259 259
Visual Impairment 257 257
No Patient Involvement 180 180
Blurred Vision 175 175
Pain 142 143
No Information 140 140
Patient Problem/Medical Problem 109 109
Tissue Damage 106 106
Visual Disturbances 105 105
Eye Injury 92 92
Device Embedded In Tissue or Plaque 82 82
Radiation Exposure, Unintended 78 78
Iatrogenic Source 78 78
Hemorrhage/Bleeding 72 72
Partial thickness (Second Degree) Burn 69 69
Corneal Clouding/Hazing 60 60
Superficial (First Degree) Burn 59 59
Neurological Deficit/Dysfunction 59 59
Headache 57 57
Edema 57 57
Foreign Body In Patient 55 55
Seizures 49 49
Burn, Thermal 45 45
Memory Loss/Impairment 45 45
Scarring 42 42
Complaint, Ill-Defined 41 41
Inflammation 40 40
Swelling 39 39
Cognitive Changes 39 39
Burning Sensation 38 38
Weakness 36 36
Urinary Tract Infection 36 36
Injury 35 35
Discomfort 35 35
Skin Discoloration 35 35
Muscle Weakness 34 34
Corneal Abrasion 33 33
Urinary Retention 33 33
Death 33 33
Scar Tissue 32 32
Foreign Body Sensation in Eye 30 30
Dry Eye(s) 30 30
Halo 29 29
Intracranial Hemorrhage 28 28
Paresis 27 27
Unspecified Infection 27 27
Hematuria 26 26
Nerve Damage 23 23
Eye Pain 23 23
Incontinence 22 22
Corneal Edema 22 22
Eye Infections 21 21
Full thickness (Third Degree) Burn 21 21
Stenosis 21 21
Red Eye(s) 20 20
Loss of Vision 20 20
Erythema 19 19
Perforation 19 19
Irritation 18 18
Thrombosis 18 18
Blood Loss 18 18
Thrombus 17 17
Hematoma 17 17
Dysuria 15 15
Hydrocephalus 14 14
Reaction 12 12
Therapeutic Effects, Unexpected 12 12
Increased Sensitivity 12 12
Corneal Perforation 12 12
Fever 11 11
Dysphasia 11 11
Nausea 11 11
Bruise/Contusion 10 10
Therapeutic Response, Decreased 10 10
Corneal Infiltrates 10 10
Unspecified Tissue Injury 10 10
Swelling/ Edema 10 10
Skin Irritation 10 10
Numbness 10 10
Urinary Frequency 9 9
Convulsion/Seizure 9 9
Hypersensitivity/Allergic reaction 9 9
Itching Sensation 9 9
Vomiting 9 9
Brain Injury 8 8
Impaired Healing 7 7
Post Operative Wound Infection 7 7
Bacterial Infection 7 7
Abscess 7 7
Pulmonary Embolism 6 6
Abrasion 6 6
Radiation Burn 6 6
Emotional Changes 6 6

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 CLINICAL LASERTHERMIA SYSTEMS AB II Jun-04-2021
8 Candela Corporation II Oct-24-2019
9 Clarus Medical, Llc II Sep-03-2021
10 Cook Inc. II Jun-14-2017
11 Cook Inc. II Jun-05-2017
12 Dornier Medtech America, Inc. II May-21-2019
13 Ellipse A/S II Jun-09-2016
14 Inova Lasers LLC II Nov-17-2020
15 Iridex Corporation II Mar-16-2018
16 Laserex Systems Inc. II Jun-06-2017
17 Leoni Fiber Optics GmbH II Dec-07-2018
18 Lumenis Limited II Oct-23-2016
19 Lumenis Ltd II May-13-2016
20 Medtronic Navigation, Inc. II May-06-2020
21 Medtronic Navigation, Inc. II Jul-19-2018
22 Medtronic Navigation, Inc. II Oct-18-2017
23 Medtronic Navigation, Inc. II Jul-03-2017
24 Medtronic Navigation, Inc. II May-16-2016
25 Medtronic Sofamor Danek USA Inc II Jul-23-2020
26 Monteris Medical Corp I Mar-20-2018
27 Monteris Medical Corp I May-16-2016
28 New Star Lasers, Inc. II Sep-30-2016
29 Olympus Corporation of the Americas II Aug-15-2021
30 Quanta System, S.p.A. II Jun-10-2021
31 Ra Medical Systems, Inc. II Apr-01-2020
32 Strata Skin Sciences, Inc. II Mar-27-2017
33 Xintec Corp III Oct-18-2019
34 Xintec Corp II Aug-02-2017
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