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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
ABBOTT MEDICAL OPTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 1
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
AMD GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 6
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOLASE, INC
  SUBSTANTIALLY EQUIVALENT 3
BIOLASE, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 2
CANDELA
  SUBSTANTIALLY EQUIVALENT 4
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 4
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 5
CYDEN LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 2
CYNOSURE, INC. DBA ELLMAN
  SUBSTANTIALLY EQUIVALENT 1
DIOTECH CO
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 3
DORNIER MEDTECH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 2
ELLIPSE A/S
  SUBSTANTIALLY EQUIVALENT 4
EQUIPMED NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOCUS MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
FORMATK SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 3
FOTONA D.D.
  SUBSTANTIALLY EQUIVALENT 1
FOTONA D.O.O.
  SUBSTANTIALLY EQUIVALENT 6
GME GERMAN MEDICAL ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 2
INMODE MD LTD.
  SUBSTANTIALLY EQUIVALENT 4
INNOVAQUARTZ LLC
  SUBSTANTIALLY EQUIVALENT 1
IRIDEX CORP.
  SUBSTANTIALLY EQUIVALENT 4
IRIDEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
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 5
LUMENIS LTD.
  SUBSTANTIALLY EQUIVALENT 6
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 11
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
OD-OS GMBH
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
OMNIGUIDE, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 20
QUANTA SYSTEM, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RAJA TRADING COMPANY, INC
  SUBSTANTIALLY EQUIVALENT 1
ROGERS SCIENCES 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
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
SILHOUET-TONE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRATA SKIN SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
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
WARD PHOTONICS LLC
  SUBSTANTIALLY EQUIVALENT 1
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

Device Problems
Fracture 3598
Temperature Problem 2964
Break 2331
Appropriate Term/Code Not Available 1280
Detachment of Device or Device Component 921
Adverse Event Without Identified Device or Use Problem 895
Fiber 709
Tip 326
Device Inoperable 243
Device Operates Differently Than Expected 238
Connector 218
Device Displays Incorrect Message 207
Overheating of Device 203
Laser 191
Device Operational Issue 178
Detachment Of Device Component 174
Unexpected Therapeutic Results 169
Crack 161
Computer Software Problem 150
Misfire 146
Insufficient Information 122
Use of Device Problem 107
Material Deformation 106
Mechanical Problem 95
Thermal Decomposition of Device 86
Degraded 81
Material Integrity Problem 79
Device Damaged Prior to Use 64
Handpiece 58
Catheter 58
Failure to Fire 56
Material Fragmentation 56
No Apparent Adverse Event 54
Charred 54
Failure to Deliver Energy 53
Melted 45
Inflation Problem 45
Improper or Incorrect Procedure or Method 44
Connection Problem 44
Device Or Device Fragments Location Unknown 43
Material Separation 42
Fiberoptic 42
No Display/Image 41
Optical Problem 39
Insufficient Heating 37
Material Perforation 37
Energy Output Problem 33
Foot Switch 32
Output Problem 30
Smoking 28
Probe 26
Calibration Problem 25
Leak/Splash 24
No Device Output 24
Optical Fiber 24
Infusion or Flow Problem 22
Cable, Electrical 22
Electrical /Electronic Property Problem 21
Device Issue 20
Bent 20
Defective Device 20
Power Problem 18
Device Component Or Accessory 18
Output below Specifications 17
Unexpected/Unintended Radiation Output 17
Incorrect, Inadequate or Imprecise Resultor Readings 17
Device Handling Problem 16
Failure to Power Up 15
Power Supply 15
Failure of Device to Self-Test 15
Imprecision 15
Unexpected Shutdown 14
Loose or Intermittent Connection 13
Tear, Rip or Hole in Device Packaging 12
Use of Incorrect Control Settings 12
Foot Pedal 12
Flare or Flash 11
Loss of or Failure to Bond 11
Display or Visual Feedback Problem 11
Noise, Audible 10
Device Stops Intermittently 10
Filter 10
Loss of Power 10
Communication or Transmission Problem 10
PC (Printed Circuit) Board 9
Human Factors Issue 9
Display 9
Difficult to Remove 9
Circuit Failure 9
Unsealed Device Packaging 8
Fire 8
Activation Problem 8
Suction Problem 8
Fluid Leak 8
Failure to Calibrate 8
Peeled/Delaminated 8
Unintended Movement 7
Energy Output To Patient Tissue Incorrect 7
Burst Container or Vessel 7
Energy Spectrum Incorrect 7
Total Device Problems 17699

Recalls
Manufacturer Recall Class Date Posted
1 Aerolase Corporation II Jan-03-2020
2 American Medical Systems Innovation Center - Silicon Valley II Jul-21-2015
3 Angiodynamics, Inc. II Aug-30-2019
4 Beijing Syntech Laser Co., Ltd II May-02-2018
5 Boston Scientific Corporation II Apr-24-2020
6 Boston Scientific Corporation II May-22-2019
7 Boston Scientific Corporation II Mar-05-2018
8 Candela Corporation II Oct-24-2019
9 Cook Inc. II Jun-14-2017
10 Cook Inc. II Jun-05-2017
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 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 Limited II Apr-24-2015
18 Lumenis Ltd II May-13-2016
19 Medtronic Navigation, Inc. II May-06-2020
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 Medtronic Sofamor Danek USA Inc II Jul-23-2020
25 Monteris Medical Corp I Mar-20-2018
26 Monteris Medical Corp I May-16-2016
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 Ra Medical Systems, Inc. II Apr-01-2020
31 Strata Skin Sciences, Inc. II Mar-27-2017
32 Xintec Corp III Oct-18-2019
33 Xintec Corp II Aug-02-2017

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