• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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 2
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 1
BEIJING SANO LASER S&T DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
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
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 3
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 5
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
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 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 1
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
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 2
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
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
MONTERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MONTERIS MEDICAL,
  SUBSTANTIALLY EQUIVALENT 1
MONTERIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MVITRO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANOSPECTRA BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 11
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
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
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
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 10
WONTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WONTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 3
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
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY 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 2339 2339
2024 2220 2251
2025 401 553

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2656 2656
Adverse Event Without Identified Device or Use Problem 2242 2402
Decrease in Suction 1373 1841
Defective Device 664 664
Firing Problem 550 550
Failure to Align 503 503
Appropriate Term/Code Not Available 458 458
Fracture 452 452
Device Displays Incorrect Message 437 437
Output Problem 331 331
Overheating of Device 303 303
Detachment of Device or Device Component 285 285
Therapeutic or Diagnostic Output Failure 281 281
Device Operational Issue 269 269
Mechanical Problem 205 205
Degraded 192 192
Fire 191 191
Output below Specifications 184 184
Power Problem 177 177
Use of Device Problem 176 176
Connection Problem 174 174
Insufficient Information 153 153
Smoking 152 152
Failure to Fire 147 147
Contamination 144 157
Thermal Decomposition of Device 112 112
No Apparent Adverse Event 110 110
Failure to Deliver Energy 95 95
Loss of or Failure to Bond 93 93
Melted 87 87
Gas Output Problem 84 84
Electrical /Electronic Property Problem 80 80
Suction Problem 78 78
Optical Problem 74 74
Computer Software Problem 71 71
Communication or Transmission Problem 67 67
Device Contaminated During Manufacture or Shipping 67 67
Noise, Audible 66 66
Material Integrity Problem 66 66
Incorrect, Inadequate or Imprecise Result or Readings 60 60
Failure to Power Up 59 59
Energy Output Problem 58 58
Suction Failure 57 57
Unexpected/Unintended Radiation Output 51 51
Improper or Incorrect Procedure or Method 48 48
Material Separation 47 47
Sparking 46 46
Physical Resistance/Sticking 45 45
Failure to Cut 44 44
Misfire 44 44

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7965 8281
No Consequences Or Impact To Patient 909 909
Insufficient Information 778 778
No Known Impact Or Consequence To Patient 616 616
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 615 787
Burn(s) 373 373
Keratitis 257 258
Visual Impairment 149 152
Blurred Vision 144 147
Eye Injury 122 123
Pain 120 120
Hemorrhage/Bleeding 103 103
Visual Disturbances 77 80
Scar Tissue 76 76
Foreign Body In Patient 71 71
Unspecified Tissue Injury 61 61
Urinary Retention 58 58
Hematuria 57 57
Blister 57 57
Superficial (First Degree) Burn 56 56
Radiation Exposure, Unintended 53 53
Swelling/ Edema 51 51
Stenosis 47 197
No Code Available 45 45
Inflammation 43 43
Muscle Weakness 40 40
Urinary Tract Infection 38 38
Urethral Stenosis/Stricture 37 37
Fever 37 37
Urinary Incontinence 36 36
No Patient Involvement 36 36
Eye Pain 36 36
Corneal Abrasion 35 35
Erythema 34 34
Partial thickness (Second Degree) Burn 34 34
Skin Discoloration 31 31
Dysuria 31 31
Intracranial Hemorrhage 30 30
Unspecified Infection 30 30
Unspecified Kidney or Urinary Problem 29 29
Perforation 29 29
Foreign Body Sensation in Eye 28 28
Full thickness (Third Degree) Burn 27 27
Tissue Damage 27 27
Discomfort 25 25
Headache 25 25
Device Embedded In Tissue or Plaque 25 25
Red Eye(s) 24 24
Hematoma 24 24
Skin Inflammation/ Irritation 23 23

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 Oct-18-2024
16 Olympus Corporation of the Americas II Aug-05-2024
17 Olympus Corporation of the Americas II Mar-27-2024
18 Olympus Corporation of the Americas II Jan-18-2024
19 Olympus Corporation of the Americas II Jan-12-2024
20 Olympus Corporation of the Americas II Jan-12-2024
21 Olympus Corporation of the Americas II Jun-28-2022
22 Olympus Corporation of the Americas II Aug-15-2021
23 Quanta System, S.p.A. II Jun-10-2021
24 Ra Medical Systems, Inc. II Apr-01-2020
25 WINGDERM ELECTRO-OPTICS LTD. II Dec-05-2024
-
-