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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 1
ABBOTT MEDICAL OPTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVALIGHT APS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED TECHNOLOGY LASER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALLMED SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
ALMA LASERS INC.
  SUBSTANTIALLY EQUIVALENT 2
ALMA LASERS LTD.
  SUBSTANTIALLY EQUIVALENT 2
ALMA LTD
  SUBSTANTIALLY EQUIVALENT 1
AMA NETWORK INC
  SUBSTANTIALLY EQUIVALENT 1
AMBICARE HEALTH LTD
  SUBSTANTIALLY EQUIVALENT 1
AMD GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 8
BEIJING ANCHORFREE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING HONKON TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
Beijing Toplaser Technology Co., Ltd.
  SUBSTANTIALLY EQUIVALENT 3
BIOLASE, INC
  SUBSTANTIALLY EQUIVALENT 2
BIOLASE, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIO-MED
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED USA INC
  SUBSTANTIALLY EQUIVALENT 1
BIO-MED USA INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BISON MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CANDELA
  SUBSTANTIALLY EQUIVALENT 4
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 4
CANDELA CORPATION
  SUBSTANTIALLY EQUIVALENT 1
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 8
CLINICAL LASERTHERMIA SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
CONVERGENT DENTAL, INC
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 7
CYDEN LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 7
CYNOSURE, INC. DBA ELLMAN
  SUBSTANTIALLY EQUIVALENT 1
DIOTECH CO
  SUBSTANTIALLY EQUIVALENT 2
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 3
DORNIER MEDTECH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
DR. WOLFGANG NEUBERGER
  SUBSTANTIALLY EQUIVALENT 1
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 2
EL.EN. S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE A/S
  SUBSTANTIALLY EQUIVALENT 3
EQUIPMED NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOCUS MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
FORMATK SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 3
FOTONA D.D.
  SUBSTANTIALLY EQUIVALENT 2
FOTONA D.O.O.
  SUBSTANTIALLY EQUIVALENT 3
G.N.S NEOLASER LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL USA DISTRIBUTION, LLC
  SUBSTANTIALLY EQUIVALENT 3
GME (GERMAN MEDICAL ENGINEERING) GMBH
  SUBSTANTIALLY EQUIVALENT 1
GME GERMAN MEDICAL ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOGAN LOVELLS US, L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
HOGUE SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
INMODE MD LTD.
  SUBSTANTIALLY EQUIVALENT 4
INNOVAQUARTZ LLC
  SUBSTANTIALLY EQUIVALENT 2
IRIDEX CORP.
  SUBSTANTIALLY EQUIVALENT 4
IRIDEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
JEISYS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO KG
  SUBSTANTIALLY EQUIVALENT 1
LASER ENGINEERING, INC
  SUBSTANTIALLY EQUIVALENT 1
LASER PERIPHERALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LASEROPTEK CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIGHT SCALPEL LLC
  SUBSTANTIALLY EQUIVALENT 1
LIGHTSCALPEL LLC
  SUBSTANTIALLY EQUIVALENT 2
LITECURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS LTD
  SUBSTANTIALLY EQUIVALENT 5
LUMENIS LTD.
  SUBSTANTIALLY EQUIVALENT 6
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 11
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
LUTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
MERIDIAN AG
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MILLENNIUM DENTAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MONTERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MONTERIS MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
MONTERIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
NEW STAR LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOVIAN HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
OBERON GMBH FIBER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
OD -OS GMBH
  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
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 16
QUANTA SYSTEM, S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
REGULATORY TECHNOLOGY SERVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROGERS SCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SCARLET RF, INC
  SUBSTANTIALLY EQUIVALENT 1
SCITON, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
SHASER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHEAUMANN LASER, INC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN GSD TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN GSD TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRATA SKIN SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNERON
  SUBSTANTIALLY EQUIVALENT 1
SYNERON MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS)
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIAX DENTAL LAB
  SUBSTANTIALLY EQUIVALENT 1
VIORA LTD.
  SUBSTANTIALLY EQUIVALENT 4
VITAGE LED LTD
  SUBSTANTIALLY EQUIVALENT 1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 2
WARD PHOTONICS LLC
  SUBSTANTIALLY EQUIVALENT 1
WON TECH
  SUBSTANTIALLY EQUIVALENT 3
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

Device Problems
Fracture 3671
Temperature Problem 3281
Break 1981
Appropriate Term/Code Not Available 1136
Adverse Event Without Identified Device or Use Problem 897
Detachment of Device or device Component 849
Fiber 683
Tip 327
Device Operates Differently Than Expected 311
Device Inoperable 255
Connector 215
Device Displays Incorrect Message 214
Detachment Of Device Component 175
Overheating of Device 164
Unexpected Therapeutic Results 163
Crack 160
Device Operational Issue 146
Laser 142
Insufficient Information 124
Misfire 117
Material Deformation 101
Use of Device Problem 88
Thermal Decomposition of Device 86
Computer Software Problem 82
Material Integrity Problem 73
Device Damaged Prior to Use 64
Charred 58
Catheter 58
Mechanical Problem 57
Material Fragmentation 53
Melted 47
Handpiece 47
Material Perforation 46
Degraded 45
Device Or Device Fragments Location Unknown 44
Material Separation 42
Improper or Incorrect Procedure or Method 42
No Display / Image 41
System 39
Inflation Problem 38
No Apparent Adverse Event 35
Fiberoptic 35
Connection Problem 33
Failure to Fire 33
Energy Output Problem 29
Failure to Deliver Energy 29
Output Problem 29
Optical Problem 28
Foot Switch 27
Electrical /Electronic Property Problem 27
Interface 25
Calibration Problem 24
Leak / Splash 24
Insufficient Heating 24
Decrease in Suction 23
Probe 22
Smoking 22
Bent 20
Device Issue 20
Cable 16
Suction Problem 15
Imprecision 15
Device Handling Problem 14
Failure to Power Up 13
Optical Fiber 13
Loss of or Failure to Bond 13
Power Supply 13
Device Component Or Accessory 13
Power Problem 13
Infusion or Flow Problem 12
Output below Specifications 12
Foot Pedal 11
Communication or Transmission Problem 11
Flare or Flash 11
Loss of Power 11
Loose or Intermittent Connection 10
Filter 10
Device Stops Intermittently 10
Fire 9
Fluid Leak 9
Noise, Audible 9
Unexpected Shutdown 9
Human Factors Issue 9
Use of Incorrect Control Settings 8
Defective Device 8
Incorrect, Inadequate or Imprecise Result or Readings 8
Failure to Calibrate 8
Activation Problem 7
Energy Output To Patient Tissue Incorrect 7
Energy Spectrum Incorrect 7
Difficult to Remove 7
Material Discolored 7
No Device Output 7
Display or Visual Feedback Problem 7
Hole In Material 7
Unintended Movement 7
Failure to Align 6
Sparking 6
PC (Printed Circuit) Board 6
Human-Device Interface Problem 6
Total Device Problems 17071

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems Innovation Center - Silicon Valley II Jul-21-2015
2 Angiodynamics, Inc. II Aug-30-2019
3 Beijing Syntech Laser Co., Ltd II May-02-2018
4 Biolase Technology Inc II Aug-18-2014
5 Boston Scientific Corporation II May-22-2019
6 Boston Scientific Corporation II Mar-05-2018
7 Boston Scientific Corporation II Oct-08-2014
8 Cook Inc. II Jun-14-2017
9 Cook Inc. II Jun-05-2017
10 Cynosure, Inc. II Nov-04-2014
11 Dornier Medtech America, Inc. II May-21-2019
12 Ellipse A/S II Jun-09-2016
13 Iridex Corporation II Mar-16-2018
14 Laser Peripherals LLC II Jul-17-2014
15 Laserex Systems Inc. II Jun-06-2017
16 Leoni Fiber Optics GmbH II Dec-07-2018
17 Lumenis Limited II Oct-23-2016
18 Lumenis Limited II Apr-24-2015
19 Lumenis Ltd II May-13-2016
20 Medtronic Navigation, Inc. II Jul-19-2018
21 Medtronic Navigation, Inc. II Oct-18-2017
22 Medtronic Navigation, Inc. II Jul-03-2017
23 Medtronic Navigation, Inc. II May-16-2016
24 Monteris Medical Corp I Mar-20-2018
25 Monteris Medical Corp I May-16-2016
26 Monteris Medical Corp II Nov-19-2014
27 New Star Lasers, Inc. II Sep-30-2016
28 New Star Lasers, Inc. II Jun-27-2015
29 Nidek Inc II Jul-14-2015
30 Nidek Inc II Aug-13-2014
31 Ra Medical Systems Inc II Jul-28-2014
32 Strata Skin Sciences, Inc. II Mar-27-2017
33 Xintec Corp II Aug-02-2017

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