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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
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
A.R.C. LASER GMBH
  SUBSTANTIALLY EQUIVALENT 3
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ACCUTECH
  SUBSTANTIALLY EQUIVALENT 1
ACE
  SUBSTANTIALLY EQUIVALENT 1
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED TECHNOLOGY LASER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
AESCULIGHT, LLC
  SUBSTANTIALLY EQUIVALENT 1
AESTHERA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
AGELESS BEAUTY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
Air Liquide Healthcare America Corporation
  SUBSTANTIALLY EQUIVALENT 1
ALCON
  SUBSTANTIALLY EQUIVALENT 6
ALLMED SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 8
ALMA LASERS LTD.
  SUBSTANTIALLY EQUIVALENT 7
ALTUS MEDICA
  SUBSTANTIALLY EQUIVALENT 3
AMERICAN LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 5
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 49
AMJET DISTRIBUTION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 13
Asclepion Laser Technologies GmbH
  SUBSTANTIALLY EQUIVALENT 18
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
B&W TEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 1
Beijing Toplaser Technology Co., Ltd.
  SUBSTANTIALLY EQUIVALENT 3
BIOLASE TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 24
BIOLITEC, INC.
  SUBSTANTIALLY EQUIVALENT 28
BIO-MED
  SUBSTANTIALLY EQUIVALENT 1
BIOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
BIOTEX, INC.
  SUBSTANTIALLY EQUIVALENT 4
BLUESHINE SRL
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 68
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 11
CARDIOFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDIOGENES
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 19
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 21
CHROMOGENEX TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CLAREBLEND, INC.
  SUBSTANTIALLY EQUIVALENT 2
CLARUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
CLINICON CORP.
  SUBSTANTIALLY EQUIVALENT 9
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
COHERENT INC.
  3
  SUBSTANTIALLY EQUIVALENT 18
CONTINUUM BIOMEDICA
  SUBSTANTIALLY EQUIVALENT 19
CONVERGENT LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
COOLTOUCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 13
CYDEN LIMITED
  SUBSTANTIALLY EQUIVALENT 5
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 78
DANISH DERMATOLOGIC DEVELOPMENT A/S
  SUBSTANTIALLY EQUIVALENT 3
DERMACARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DINONA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIOMED, LTD.
  SUBSTANTIALLY EQUIVALENT 8
DIOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 23
DUSA PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDGE
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 7
ELEME MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELEXXION
  SUBSTANTIALLY EQUIVALENT 2
ELLEX, INC.
  SUBSTANTIALLY EQUIVALENT 4
Ellipse A/S
  SUBSTANTIALLY EQUIVALENT 4
ENDOPHOTONIX, INC
  SUBSTANTIALLY EQUIVALENT 1
ENERGIST, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ERCHONIA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ESPANSIONE MARKETING SPA
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 4
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 7
F.P. RUBINSTEIN Y CIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
FOTONA D.D.
  SUBSTANTIALLY EQUIVALENT 25
GENERAL PROJECT
  SUBSTANTIALLY EQUIVALENT 1
GENESIS BIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GREENTON (LONDON) LTD.
  SUBSTANTIALLY EQUIVALENT 1
HILLARD W. WELCH
  SUBSTANTIALLY EQUIVALENT 1
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 2
HOME SKINOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 2
HOWARD INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOYA CONBIO, INC
  SUBSTANTIALLY EQUIVALENT 8
HOYA PHOTONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
I.C. MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
INCISIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INNOVAQUARTZ
  SUBSTANTIALLY EQUIVALENT 2
INOLASE 2002, LTD.
  SUBSTANTIALLY EQUIVALENT 3
INTERNATIONAL BIOPHYSICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTRALASE CORP.
  SUBSTANTIALLY EQUIVALENT 9
IRIDEX CORP.
  SUBSTANTIALLY EQUIVALENT 12
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
JUNIPER MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
KAVO
  SUBSTANTIALLY EQUIVALENT 4
LASER MAX MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 4
LASER PAIN CLINICS LP
  SUBSTANTIALLY EQUIVALENT 1
LASER PERIPHERALS LLC.
  SUBSTANTIALLY EQUIVALENT 7
LASERING S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
LASEROPTEK CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 7
LIGHT BIOSCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIGHT INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 3
LIGHTWAVE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
LITECURE, LLC
  SUBSTANTIALLY EQUIVALENT 2
LUMEN
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 49
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
LYNTON LASERS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
MCCUE
  SUBSTANTIALLY EQUIVALENT 2
MEDIC SHARPLIGHT LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALCV, INC.
  SUBSTANTIALLY EQUIVALENT 5
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MILESMAN S.L.
  SUBSTANTIALLY EQUIVALENT 1
MONTERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MOOR INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 4
NANOLITE TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEW STAR LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 27
NIDEK CO
  SUBSTANTIALLY EQUIVALENT 1
NORTH AMERICAN CLINICAL LASERS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
OMNIGUIDE, INC.
  SUBSTANTIALLY EQUIVALENT 11
OPTIMEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 3
OROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSYRIS
  SUBSTANTIALLY EQUIVALENT 3
PALOMAR MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 38
PENNTACK ENTERPRISES INC.
  SUBSTANTIALLY EQUIVALENT 1
PEREGRINE SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHAROS LIFE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PHOTO THERAPEUTICS LIMITED
  SUBSTANTIALLY EQUIVALENT 4
PHOTOMEDEX, INC.
  SUBSTANTIALLY EQUIVALENT 10
PHOTONOVA OFSWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1
PLC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 2
QUANTA SYSTEM, S.P.A.
  SUBSTANTIALLY EQUIVALENT 15
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 9
RA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIANCY
  SUBSTANTIALLY EQUIVALENT 10
REGULATORY INSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIANT MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 18
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 1
SCILEX, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCITON, INC.
  SUBSTANTIALLY EQUIVALENT 15
SHANGHAI WONDERFUL OPTELECTRICS TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHARPLIGHT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIE LTD SURGICAL INSTRUMENT ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
SILVER BAY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 5
SPECTRUM
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 35
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNERON
  SUBSTANTIALLY EQUIVALENT 21
THERALIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1
TISSUE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRANSAMERICAN TECHNOLOGIES INTL.
  SUBSTANTIALLY EQUIVALENT 1
TRANSVERSE INDUSTRIES CO.
  SUBSTANTIALLY EQUIVALENT 1
TRIMEDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 48
TYRELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 13
W.O.M. WORLD OF MEDICINE AG
  SUBSTANTIALLY EQUIVALENT 3
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WAVELIGHT
  SUBSTANTIALLY EQUIVALENT 8
XINTEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 27
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAP LASERS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ZELTIQ AESTHETICS
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Fracture 2042
Temperature issue 1898
No code available 1218
Break 961
No Known Device Problem 561
Detachment of device or device component 527
Device displays error message 338
Device operates differently than expected 335
Output issue 314
Device inoperable 230
Material perforation 108
No Information 81
Burn of device or device component 78
Overheating of device or device component 76
Material integrity issue 67
Device or device fragments location unknown 55
Detachment of device component 47
Decrease in suction 46
No display or display failure 46
Failure to cut 45
Material deformation 43
Crack 42
Suction issue 41
Charred 40
Energy output to patient tissue incorrect 35
Normal 33
Loss of power 33
Material separation 31
Protective measure issue 31
Device damaged prior to use 29
Use of Device Issue 27
Misfire 22
Melted 22
Failure to deliver energy 21
Electrical issue 21
Failure to align 21
Improper or incorrect procedure or method 17
Fiberoptic break/separation 16
Connection issue 16
Bent 15
Device Issue 14
Device stops intermittently 14
Smoking 13
Material fragmentation 13
Inflation issue 12
Optical issue 12
Output energy incorrect 11
Failure to power-up 11
Fire 10
Loss of or failure to bond 10
Operating system becomes non-functional 10
Failure to fire 10
Flare or flash 9
Unintended movement 9
Not Applicable 8
Power source issue 8
Computer software issue 8
Leak 7
Premature end-of-life indicator 7
Other (for use when an appropriate device code cannot be identified) 7
Improper device output 7
Communication or transmission issue 7
Output below specifications 6
Device handling issue 6
Unknown (for use when the device problem is not known) 6
Imprecision 6
Degraded 6
Circuit Failure 5
Burst 5
Hole in material 5
Kinked 5
Device expiration issue 5
Fluid leak 5
Loose or intermittent connection 5
Misfocusing 5
Prompts will not clear 5
Decreased sensitivity 5
Positioning Issue 5
Calibration issue 5
Patient-device incompatibility 4
Device or device component damaged by another device 4
Failure to shut off 4
Packaging issue 4
Failure to calibrate 4
Component missing 4
Tip breakage 4
Difficult to remove 4
Replace 4
Unsealed device packaging 4
Failure to read input signal 4
Sticking 4
Output above specifications 4
Laser tip separation 4
Mechanical issue 3
Intra-cavity procedure, fiberoptic break or fragmentation during 3
Image display error 3
Component(s), broken 3
Application interface becomes non-functional or program exits abnormally 3
Shelf life exceeded 3
Slippage of device or device component 3
Total Device Problems 10013

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 1 0
Class II 1 3 2 3 2 4 9 7 4 5 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AMD Lasers, LLC II Sep-10-2010
2 AMS Innovative Center - San Jose II Jan-22-2013
3 AMS Innovative Center - San Jose II Feb-14-2011
4 AMS Innovative Center - San Jose II Dec-29-2010
5 AMS Innovative Center - San Jose II Sep-25-2010
6 AMS Innovative Center - San Jose II Mar-20-2008
7 AMS Innovative Center - San Jose II Feb-26-2008
8 Aerolase II Mar-29-2012
9 American Medical Systems Innovation Center - Silicon Valley II Jul-21-2015
10 Angiodynamics Worldwide Headquarters II Jan-13-2012
11 Angiodynamics Worldwide Headquarters II Jan-11-2012
12 Angiodynamics, Inc. II May-25-2013
13 Biolase Technology Inc II Aug-18-2014
14 Boston Scientific Corporation II Oct-08-2014
15 Candela Corporation II Nov-18-2013
16 Candela Laser Corporation II Feb-15-2007
17 ConBio, a CynoSure Company II Jun-26-2013
18 Convergent Dental II Oct-22-2013
19 Cynosure, Inc. II Nov-04-2014
20 Discus Dental LLC II Apr-29-2013
21 Ellipse A/S II Jun-09-2016
22 Laser Peripherals LLC II Jul-17-2014
23 Lumenis Limited II Oct-23-2016
24 Lumenis Limited II Apr-24-2015
25 Lumenis Ltd II May-13-2016
26 Lumenis, Inc. II Sep-11-2013
27 Lumenis, Inc. II Apr-09-2008
28 Medtronic Navigation, Inc. II May-16-2016
29 Monteris Medical Corp I May-16-2016
30 Monteris Medical Corp II Nov-19-2014
31 New Star Lasers, Inc. II Sep-30-2016
32 New Star Lasers, Inc. II Jun-27-2015
33 Nidek Inc II Jul-14-2015
34 Nidek Inc II Aug-13-2014
35 OmniGuide, Inc. II Dec-03-2012
36 PhotoMedex, Inc. II Oct-01-2013
37 Quanta System, S.p.A. II Jan-17-2013
38 Ra Medical Systems Inc II Jul-28-2014
39 Sterilmed Inc II Jan-13-2009
40 Sybaritic, Inc II Sep-03-2009
41 Vascular Solutions, Inc. II Mar-03-2011

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