TPLC - Total Product Life Cycle

• 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 Code: GEX
• Regulation Number: 878.4810
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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