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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
ACCLARO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ACCURE ACNE, INC
  SUBSTANTIALLY EQUIVALENT 1
ACCURE ACNE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVALIGHT APS
  SUBSTANTIALLY EQUIVALENT 1
AESTHETIC TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
AESTHETIC TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALLENGERS GLOBAL HEALTHCARE PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
ALMA LASERS INC.
  SUBSTANTIALLY EQUIVALENT 2
ALMA LASERS, INC
  SUBSTANTIALLY EQUIVALENT 1
ALMA LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALMA LASERS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
AMI INC.
  SUBSTANTIALLY EQUIVALENT 1
AMT ENGINEERING CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 6
AVAVA, INC
  SUBSTANTIALLY EQUIVALENT 1
AVENDA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
AZENA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BEIJING ADSS DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING GLOBALIPL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING HUACHENG TAIKE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING LASERTELL MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING LEAD BEAUTY S & T CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
BEIJING MEGA BEAUTY TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING NUBWAY S&T CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING SANO LASER S&T DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
BEIJING SANO LASER S&T DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING SANO LASER S&T DEVELOPMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGYCO.LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING STAR NEW TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING STELLE LASER TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING SUPERLASER TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING UNT TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING UNT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING WINKONLASER TECHNOLOGY LIMITED.
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED USA INC
  SUBSTANTIALLY EQUIVALENT 2
BIOLASE, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOLASE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
BIOTEC ITALIA, SRL
  SUBSTANTIALLY EQUIVALENT 1
BLUECORE COMPANY CO LTD
  SUBSTANTIALLY EQUIVALENT 1
BLUECORE COMPANY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BT BEAMEDICAL TACHNOOGIES LTD. (BEAMED)
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION (CPMT LASER)
  SUBSTANTIALLY EQUIVALENT 2
CANDELA CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CERAMOPTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL LASERTHERMIA SYSTEMS, AB
  SUBSTANTIALLY EQUIVALENT 1
CONVERGENT LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CPMT LASER (CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION)
  SUBSTANTIALLY EQUIVALENT 1
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 4
CYNOSURE LLC
  SUBSTANTIALLY EQUIVALENT 2
CYNOSURE, LLC.
  SUBSTANTIALLY EQUIVALENT 1
D.E.A PROJECT S.R.1.
  SUBSTANTIALLY EQUIVALENT 1
DAEJU MEDITECH ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DAESHIN ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DORNIERMEDTECH AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
EL. EN ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
EL. EN. S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
EL.EN ELECTROINC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
EL.EN ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 3
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
EL.EN. S.P.A.
  SUBSTANTIALLY EQUIVALENT 6
ELESTA SPA
  SUBSTANTIALLY EQUIVALENT 2
ELLIPSE A/S
  SUBSTANTIALLY EQUIVALENT 1
EMOLED, SRL
  SUBSTANTIALLY EQUIVALENT 1
ENAMEL PURE
  SUBSTANTIALLY EQUIVALENT 1
ENDYMED MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
EPILADY 2000 LLC
  SUBSTANTIALLY EQUIVALENT 2
FA INTERNATIONAL, LP
  SUBSTANTIALLY EQUIVALENT 1
FABINJECT LNDUSTRIA E COMERCIO LMPORTACAO E EXPORTACAO LTDA
  SUBSTANTIALLY EQUIVALENT 1
FOTONA D.O.O.
  SUBSTANTIALLY EQUIVALENT 9
G.N.S NEOLASER LTD.
  SUBSTANTIALLY EQUIVALENT 1
GIGAALASER COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 2
GLOBAL MED SYSTEMS SL
  SUBSTANTIALLY EQUIVALENT 1
GME GERMAN MEDICAL ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU CHUANG ZAO MEI TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU CHUANG ZAO MEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEBEI JT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI KEYLASER SCI-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI ZHEMAI TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
HIGH TECHNOLOGY PRODUCTS SLU
  SUBSTANTIALLY EQUIVALENT 2
HIRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HULASER, INC.
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GROUP S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
IDS, LIMITED
  SUBSTANTIALLY EQUIVALENT 1
IDS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO LTD
  SUBSTANTIALLY EQUIVALENT 2
ILOODA CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 2
ILOODA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INMODE LTD.
  SUBSTANTIALLY EQUIVALENT 2
INNOVAQUARTZ LLC
  SUBSTANTIALLY EQUIVALENT 2
INNOVOYCE
  SUBSTANTIALLY EQUIVALENT 1
INNOVOYCE LLC
  SUBSTANTIALLY EQUIVALENT 1
INWOUND APS
  SUBSTANTIALLY EQUIVALENT 1
IPG MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IPG MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IVYLASER (BEIJING) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
IVYLASER (BEIJING) TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2
JIANGXI MEDEX TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI MEDEX TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LASER ENGINEERING, INC.
  SUBSTANTIALLY EQUIVALENT 1
LASEROPTEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
LEASEIR TECHNOLOGIES S.L.U.
  SUBSTANTIALLY EQUIVALENT 1
LEONI FIBER OPTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHT GUIDE OPTICS INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTSCALPEL INC
  SUBSTANTIALLY EQUIVALENT 1
LIGHTSENSE TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
LISA LASER PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
LMG LASERS COMERCIO, IMPORTACAO E EXPORTACAO LTDA
  SUBSTANTIALLY EQUIVALENT 1
LOTUXS MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS BE LTD.
  SUBSTANTIALLY EQUIVALENT 3
LUMENIS BE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS LTD.
  SUBSTANTIALLY EQUIVALENT 4
LUMENIS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
LUVO MEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 3
M&T S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
M&T SRL
  SUBSTANTIALLY EQUIVALENT 1
MATELASER, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDENCY S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SAN INDÚSTRIA DE EQUIPAMENTOS MÉDICOS LTDA
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SAN INDÚSTRIA DE EQUIPAMENTOS MÉDICOS LTDA.
  SUBSTANTIALLY EQUIVALENT 1
MEDICO USA INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREATIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDMIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEGABAY S.A.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-ENERGY MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MONTERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MONTERIS MEDICAL,
  SUBSTANTIALLY EQUIVALENT 1
MONTERIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MVITRO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANJING BESTVIEW LASER S&T CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANOSPECTRA BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEAUVIA NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
OMNI-GUIDE HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OMNIGUIDE, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUANTA SYSTEM S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
QUANTA SYSTEM SPA
  SUBSTANTIALLY EQUIVALENT 12
QUANTA SYSTEM, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
RAJA TRADING COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 2
REALTON (SUZHOU) MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
REALTON (SUZHOU) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
REVEAL LASERS LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHEIN LASER TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
RISU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SANHE LASERCONN TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCITON, INC
  SUBSTANTIALLY EQUIVALENT 2
SENTIENT MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG MOONLIGHT ELECTRONICS TECH CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI OMNI LASER SKINOLOGY 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 2
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMEDTRUM MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SNJ CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SNJ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLAR LS CJSC
  SUBSTANTIALLY EQUIVALENT 1
SOLITON INC.
  SUBSTANTIALLY EQUIVALENT 4
SOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SOLTA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SQUALUS MED LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRATA SKIN SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUN PHARMACEUTICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERMOSALUD
  SUBSTANTIALLY EQUIVALENT 2
THERALASER MEDTECH (CHINA) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRIANGEL RSD LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT USA INC.
  SUBSTANTIALLY EQUIVALENT 1
VYDENCE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 2
W & R INVESTMENTS, LLC DBA LASER ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
WEIFANG DRAGONFLY ELECTRONICS TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WEIFANG MINGLIANG ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WEIFANG MINGLIANG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WON TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
WONTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WONTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
WUHAN DIMED LASER TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUHAN LOTUXS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WUHAN PIOON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WUHAN PIOON TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 4
XEMIS MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YASSEN WELLNESS LLC
  SUBSTANTIALLY EQUIVALENT 1
ZELTIQ AESTHETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ZELTIQ AESTHETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHENGZHOU BESTVIEW ST CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUOZHOU SUMMER STAR TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER MEDIZINSYSTEME GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2182 2182
2021 3465 3465
2022 2288 2752
2023 2338 2338
2024 2220 2251
2025 1350 1515

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2940 2940
Adverse Event Without Identified Device or Use Problem 2459 2619
Decrease in Suction 1377 1847
Defective Device 728 728
Firing Problem 585 585
Failure to Align 515 515
Device Displays Incorrect Message 489 489
Appropriate Term/Code Not Available 480 480
Fracture 459 459
Output Problem 335 335
Overheating of Device 313 313
Detachment of Device or Device Component 296 296
Therapeutic or Diagnostic Output Failure 282 282
Device Operational Issue 269 269
Mechanical Problem 219 224
Use of Device Problem 210 210
Fire 209 209
Output below Specifications 208 208
Smoking 199 199
Degraded 192 192
Power Problem 192 192
Connection Problem 185 185
Insufficient Information 160 160
Failure to Fire 148 148
Contamination 144 157
Thermal Decomposition of Device 127 127
No Apparent Adverse Event 115 115
Unexpected Therapeutic Results 103 103
Melted 96 96
Failure to Deliver Energy 95 95
Loss of or Failure to Bond 95 95
Suction Problem 90 90
Gas Output Problem 88 88
Noise, Audible 85 85
Electrical /Electronic Property Problem 80 80
Communication or Transmission Problem 80 83
Material Integrity Problem 77 77
Optical Problem 74 74
Computer Software Problem 74 74
Device Contaminated During Manufacture or Shipping 69 69
Incorrect, Inadequate or Imprecise Result or Readings 64 64
Failure to Power Up 63 63
Energy Output Problem 62 62
Suction Failure 57 57
Unexpected/Unintended Radiation Output 56 56
Sparking 53 53
Improper or Incorrect Procedure or Method 52 52
Physical Resistance/Sticking 49 49
Material Separation 48 48
Use of Incorrect Control/Treatment Settings 47 47

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8605 8929
No Consequences Or Impact To Patient 909 909
Insufficient Information 863 863
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 637 813
No Known Impact Or Consequence To Patient 616 616
Burn(s) 432 432
Keratitis 270 271
Visual Impairment 151 154
Blurred Vision 146 149
Eye Injury 127 129
Hemorrhage/Bleeding 126 126
Pain 126 126
Visual Disturbances 91 94
Urinary Retention 88 88
Hematuria 87 87
Scar Tissue 82 82
Foreign Body In Patient 81 81
Unspecified Tissue Injury 72 72
Blister 65 65
Urinary Tract Infection 60 60
Urethral Stenosis/Stricture 59 59
Superficial (First Degree) Burn 57 57
Stenosis 56 206
Swelling/ Edema 54 54
Radiation Exposure, Unintended 53 53
Fever 49 49
Inflammation 47 47
Urinary Incontinence 46 46
No Code Available 45 45
Muscle Weakness 41 41
Perforation 40 40
Erythema 40 40
Eye Pain 37 37
Partial thickness (Second Degree) Burn 37 37
No Patient Involvement 36 36
Corneal Abrasion 35 35
Unspecified Infection 33 33
Dysuria 33 33
Intracranial Hemorrhage 32 32
Skin Discoloration 32 32
Unspecified Kidney or Urinary Problem 29 29
Sepsis 29 29
Foreign Body Sensation in Eye 28 28
Full thickness (Third Degree) Burn 28 28
Tissue Damage 27 27
Device Embedded In Tissue or Plaque 26 26
Discomfort 26 26
Hematoma 25 25
Headache 25 25
Micturition Urgency 24 24

Recalls
Manufacturer Recall Class Date Posted
1 Accure Acne, Inc II Jan-20-2024
2 Advance-Esthetic LLC II Oct-13-2023
3 Aerolase Corporation II Jan-03-2020
4 Angiodynamics, Inc. II Sep-27-2022
5 Boston Scientific Corporation II Jul-21-2023
6 Boston Scientific Corporation III Jul-15-2022
7 Boston Scientific Corporation II Apr-24-2020
8 CLINICAL LASERTHERMIA SYSTEMS AB II Jun-04-2021
9 Clarus Medical, Llc II Sep-03-2021
10 Inova Lasers LLC II Nov-17-2020
11 Karl Storz Endoscopy II May-13-2024
12 LUMENIS, LTD. II Mar-05-2025
13 Medtronic Navigation, Inc. II May-06-2020
14 Medtronic Sofamor Danek USA Inc II Jul-23-2020
15 Olympus Corporation of the Americas II Jun-06-2025
16 Olympus Corporation of the Americas II May-01-2025
17 Olympus Corporation of the Americas II Oct-18-2024
18 Olympus Corporation of the Americas II Aug-05-2024
19 Olympus Corporation of the Americas II Mar-27-2024
20 Olympus Corporation of the Americas II Jan-18-2024
21 Olympus Corporation of the Americas II Jan-12-2024
22 Olympus Corporation of the Americas II Jan-12-2024
23 Olympus Corporation of the Americas II Jun-28-2022
24 Olympus Corporation of the Americas II Aug-15-2021
25 Quanta System, S.p.A. II Jun-10-2021
26 Ra Medical Systems, Inc. II Apr-01-2020
27 WINGDERM ELECTRO-OPTICS LTD. II Dec-05-2024
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