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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 1
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 5
BIOLASE, INC
  SUBSTANTIALLY EQUIVALENT 2
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 3
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 3
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 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 1
FOTONA D.O.O.
  SUBSTANTIALLY EQUIVALENT 4
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 5
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 10
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
LUTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
M&T SRL
  SUBSTANTIALLY EQUIVALENT 1
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 17
QUANTA SYSTEM, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  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 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
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
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 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 3452
Temperature Problem 2964
Break 2124
Appropriate Term/Code Not Available 1158
Detachment of Device or device Component 851
Adverse Event Without Identified Device or Use Problem 817
Fiber 691
Tip 326
Device Inoperable 243
Device Operates Differently Than Expected 238
Connector 216
Device Displays Incorrect Message 205
Overheating of Device 180
Detachment Of Device Component 174
Unexpected Therapeutic Results 165
Crack 159
Laser 154
Device Operational Issue 152
Misfire 128
Insufficient Information 120
Material Deformation 105
Computer Software Problem 102
Use of Device Problem 99
Thermal Decomposition of Device 84
Material Integrity Problem 73
Mechanical Problem 72
Device Damaged Prior to Use 64
Catheter 58
Handpiece 57
Charred 54
Material Fragmentation 51
Degraded 50
No Apparent Adverse Event 46
Improper or Incorrect Procedure or Method 43
Device Or Device Fragments Location Unknown 43
Melted 43
Material Separation 40
Inflation Problem 40
Failure to Fire 40
No Display / Image 40
Fiberoptic 37
Material Perforation 37
Connection Problem 36
Optical Problem 34
Insufficient Heating 33
Energy Output Problem 31
Failure to Deliver Energy 31
Foot Switch 29
Output Problem 29
Calibration Problem 25
Leak / Splash 24
Smoking 24
Probe 23
Electrical /Electronic Property Problem 21
Infusion or Flow Problem 20
Cable 20
Device Issue 20
Bent 20
Optical Fiber 18
Device Component Or Accessory 18
Power Problem 16
Device Handling Problem 15
Imprecision 15
Power Supply 14
Output below Specifications 14
Failure to Power Up 13
Unexpected Shutdown 12
Failure of Device to Self-Test 11
Use of Incorrect Control Settings 11
Flare or Flash 11
Foot Pedal 11
Loose or Intermittent Connection 11
No Device Output 11
Display or Visual Feedback Problem 10
Loss of Power 10
Communication or Transmission Problem 10
Incorrect, Inadequate or Imprecise Result or Readings 10
Filter 10
Defective Device 10
Device Stops Intermittently 10
Loss of or Failure to Bond 10
Human Factors Issue 9
Unexpected/Unintended Radiation Output 9
PC (Printed Circuit) Board 9
Circuit Failure 9
Noise, Audible 9
Suction Problem 8
Difficult to Remove 8
Fire 8
Failure to Calibrate 8
Fluid Leak 8
Energy Output To Patient Tissue Incorrect 7
Unintended Movement 7
Unsealed Device Packaging 7
Activation Problem 7
Hole In Material 7
Material Discolored 7
Sparking 7
Energy Spectrum Incorrect 7
Display 7
Total Device Problems 16644

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 May-22-2019
6 Boston Scientific Corporation II Mar-05-2018
7 Candela Corporation II Oct-24-2019
8 Cook Inc. II Jun-14-2017
9 Cook Inc. II Jun-05-2017
10 Dornier Medtech America, Inc. II May-21-2019
11 Ellipse A/S II Jun-09-2016
12 Iridex Corporation II Mar-16-2018
13 Laserex Systems Inc. II Jun-06-2017
14 Leoni Fiber Optics GmbH II Dec-07-2018
15 Lumenis Limited II Oct-23-2016
16 Lumenis Limited II Apr-24-2015
17 Lumenis Ltd II May-13-2016
18 Medtronic Navigation, Inc. II Jul-19-2018
19 Medtronic Navigation, Inc. II Oct-18-2017
20 Medtronic Navigation, Inc. II Jul-03-2017
21 Medtronic Navigation, Inc. II May-16-2016
22 Monteris Medical Corp I Mar-20-2018
23 Monteris Medical Corp I May-16-2016
24 New Star Lasers, Inc. II Sep-30-2016
25 New Star Lasers, Inc. II Jun-27-2015
26 Nidek Inc II Jul-14-2015
27 Strata Skin Sciences, Inc. II Mar-27-2017
28 Xintec Corp III Oct-18-2019
29 Xintec Corp II Aug-02-2017

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