TPLC - Total Product Life Cycle

• Device: powered laser surgical instrument
• 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
ACCLARO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ACCURE ACNE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC TECHNOLOGY LTD
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	1
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALLENGERS GLOBAL HEALTHCARE PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ALMA LASERS INC.
	SUBSTANTIALLY EQUIVALENT	2
ALMA LASERS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ALMA LASERS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
AMI INC.
	SUBSTANTIALLY EQUIVALENT	1
AMT ENGINEERING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASCLEPION LASER TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	6
AVAVA, INC
	SUBSTANTIALLY EQUIVALENT	1
AVENDA HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
AZENA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BEIJING ADSS DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING GLOBALIPL DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING HUACHENG TAIKE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING LASERTELL MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING LEAD BEAUTY S & T CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
BEIJING SANO LASER S&T DEVELOPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGYCO.LTD
	SUBSTANTIALLY EQUIVALENT	1
BEIJING STAR NEW TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING STELLE LASER TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING SUPERLASER TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
BEIJING UNT TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BEIJING UNT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIO-MED USA INC
	SUBSTANTIALLY EQUIVALENT	2
BIOLASE, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOLASE, INC.
	SUBSTANTIALLY EQUIVALENT	3
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
BIOTEC ITALIA, SRL
	SUBSTANTIALLY EQUIVALENT	1
BLUECORE COMPANY CO LTD
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BT BEAMEDICAL TACHNOOGIES LTD. (BEAMED)
	SUBSTANTIALLY EQUIVALENT	1
CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION (CPMT LASER)
	SUBSTANTIALLY EQUIVALENT	2
CANDELA CORP.
	SUBSTANTIALLY EQUIVALENT	1
CANDELA CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
CAO GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	3
CERAMOPTEC GMBH
	SUBSTANTIALLY EQUIVALENT	1
CLINICAL LASERTHERMIA SYSTEMS, AB
	SUBSTANTIALLY EQUIVALENT	1
CONVERGENT LASER TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CPMT LASER (CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION)
	SUBSTANTIALLY EQUIVALENT	1
CUTERA, INC.
	SUBSTANTIALLY EQUIVALENT	3
CYNOSURE LLC
	SUBSTANTIALLY EQUIVALENT	2
CYNOSURE, LLC.
	SUBSTANTIALLY EQUIVALENT	1
D.E.A PROJECT S.R.1.
	SUBSTANTIALLY EQUIVALENT	1
DAEJU MEDITECH ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DAESHIN ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DORNIERMEDTECH AMERICA, INC
	SUBSTANTIALLY EQUIVALENT	1
EL. EN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
EL. EN. S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
EL..EN. ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
EL.EN ELECTROINC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
EL.EN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	3
EL.EN. ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
EL.EN. S.P.A.
	SUBSTANTIALLY EQUIVALENT	5
ELESTA SPA
	SUBSTANTIALLY EQUIVALENT	2
ELLIPSE A/S
	SUBSTANTIALLY EQUIVALENT	1
EMOLED, SRL
	SUBSTANTIALLY EQUIVALENT	1
ENAMEL PURE
	SUBSTANTIALLY EQUIVALENT	1
ENDYMED MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
EPILADY 2000 LLC
	SUBSTANTIALLY EQUIVALENT	2
FA INTERNATIONAL, LP
	SUBSTANTIALLY EQUIVALENT	1
FOTONA D.O.O.
	SUBSTANTIALLY EQUIVALENT	9
GLOBAL MED SYSTEMS SL
	SUBSTANTIALLY EQUIVALENT	1
GME GERMAN MEDICAL ENGINEERING GMBH
	SUBSTANTIALLY EQUIVALENT	3
GUANGZHOU CHUANG ZAO MEI TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
HEBEI ZHEMAI TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
HIGH TECHNOLOGY PRODUCTS SLU
	SUBSTANTIALLY EQUIVALENT	3
HIRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HULASER, INC.
	SUBSTANTIALLY EQUIVALENT	1
I.T.S. GROUP S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
IDS, LIMITED
	SUBSTANTIALLY EQUIVALENT	1
IDS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO LTD
	SUBSTANTIALLY EQUIVALENT	2
ILOODA CO,.LTD.
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INMODE LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVAQUARTZ LLC
	SUBSTANTIALLY EQUIVALENT	2
INNOVOYCE
	SUBSTANTIALLY EQUIVALENT	1
INNOVOYCE LLC
	SUBSTANTIALLY EQUIVALENT	1
INWOUND APS
	SUBSTANTIALLY EQUIVALENT	1
IPG MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
IPG MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
IVYLASER (BEIJING) TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	2
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
LASER ENGINEERING, INC.
	SUBSTANTIALLY EQUIVALENT	1
LASEROPTEK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
LEASEIR TECHNOLOGIES S.L.U.
	SUBSTANTIALLY EQUIVALENT	1
LEONI FIBER OPTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSCALPEL INC
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSENSE TECHNOLOGIES LTD
	SUBSTANTIALLY EQUIVALENT	1
LISA LASER PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
LMG LASERS COMERCIO, IMPORTACAO E EXPORTACAO LTDA
	SUBSTANTIALLY EQUIVALENT	1
LOTUXS MEDTECH (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS BE LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS BE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS INC.
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS LTD.
	SUBSTANTIALLY EQUIVALENT	4
LUMENIS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
LUTRONIC GLOBAL
	SUBSTANTIALLY EQUIVALENT	1
LUVO MEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	3
M&T SRL
	SUBSTANTIALLY EQUIVALENT	2
MEDICAL SAN INDÚSTRIA DE EQUIPAMENTOS MÉDICOS LTDA
	SUBSTANTIALLY EQUIVALENT	1
MEDICO USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDMIX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEGABAY S.A.
	SUBSTANTIALLY EQUIVALENT	1
MILLENNIUM DENTAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MONTERIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
MONTERIS MEDICAL,
	SUBSTANTIALLY EQUIVALENT	1
MONTERIS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANOSPECTRA BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEAUVIA NORTH AMERICA
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	1
OMNI-GUIDE HOLDINGS, INC.
	SUBSTANTIALLY EQUIVALENT	2
OMNIGUIDE, INC.
	SUBSTANTIALLY EQUIVALENT	2
QUANTA SYSTEM SPA
	SUBSTANTIALLY EQUIVALENT	10
QUANTA SYSTEM, S.P.A
	SUBSTANTIALLY EQUIVALENT	1
QUANTA SYSTEM, S.P.A.
	SUBSTANTIALLY EQUIVALENT	2
QUANTEL MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
RAJA TRADING COMPANY, INC.
	SUBSTANTIALLY EQUIVALENT	2
REALTON (SUZHOU) MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
REALTON (SUZHOU) MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
REVEALLUX, CORP
	SUBSTANTIALLY EQUIVALENT	1
RHEIN LASER TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ROHRER AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1
ROHRER AESTHETICS, LLC
	SUBSTANTIALLY EQUIVALENT	3
SAN HE LEFIS ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SANHE LASERCONN TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SCITON, INC
	SUBSTANTIALLY EQUIVALENT	3
SENTIENT MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI OMNI LASER SKINOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHARPLIGHT TECHNOLOGIES LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN GSD TECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN GSD TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SILHOUET-TONE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SMEDTRUM MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SNJ CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SNJ CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLITON INC.
	SUBSTANTIALLY EQUIVALENT	5
SOLTA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SQUALUS MED LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRATA SKIN SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUN PHARMACEUTICAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TERMOSALUD
	SUBSTANTIALLY EQUIVALENT	1
THERALASER MEDTECH (CHINA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TRIANGEL RSD LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VENUS CONCEPT USA INC.
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	3
W & R INVESTMENTS, LLC DBA LASER ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
WEIFANG KM ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WEIFANG MINGLIANG ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WINGDERM ELECTRO-OPTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
WON TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	11
WONTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN DIMED LASER TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN LOTUXS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WUHAN PIOON TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WUHAN PIOON TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	3
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YASSEN WELLNESS LLC
	SUBSTANTIALLY EQUIVALENT	1
ZELTIQ AESTHETICS INC.
	SUBSTANTIALLY EQUIVALENT	1
ZELTIQ AESTHETICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZHENGZHOU BESTVIEW ST CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER MEDIZINSYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	2709	2709
2020	2182	2182
2021	3465	3465
2022	2288	2752
2023	2339	2339
2024	1098	1108

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2905	2905
Adverse Event Without Identified Device or Use Problem	2243	2245
Decrease in Suction	1362	1826
Fracture	897	897
Appropriate Term/Code Not Available	621	621
Defective Device	600	600
Firing Problem	489	489
Detachment of Device or Device Component	447	447
Therapeutic or Diagnostic Output Failure	445	445
Device Displays Incorrect Message	365	365
Output Problem	356	356
Failure to Align	339	339
Overheating of Device	328	328
Device Operational Issue	247	247
Mechanical Problem	234	234
Degraded	231	231
Connection Problem	177	177
Use of Device Problem	176	176
Failure to Fire	174	174
Fire	171	171
Insufficient Information	161	161
Power Problem	150	150
Contamination	137	143
Computer Software Problem	134	134
Output below Specifications	121	121
No Apparent Adverse Event	120	120
Failure to Deliver Energy	112	112
Smoking	112	112
Suction Problem	112	112
Thermal Decomposition of Device	94	94
Misfire	93	93
Optical Problem	91	91
Suction Failure	90	90
Loss of or Failure to Bond	90	90
Electrical /Electronic Property Problem	87	87
Incorrect, Inadequate or Imprecise Result or Readings	83	83
Gas Output Problem	79	79
Melted	77	77
Energy Output Problem	72	72
Material Integrity Problem	68	68
Device Contaminated During Manufacture or Shipping	67	67
Failure to Cut	67	67
Improper or Incorrect Procedure or Method	64	64
Communication or Transmission Problem	57	57
Noise, Audible	51	51
Material Deformation	49	49
Unexpected/Unintended Radiation Output	48	48
No Device Output	48	48
Failure to Power Up	48	48
Material Fragmentation	47	47
Sparking	47	47
Defective Component	46	46
Material Separation	46	46
Insufficient Heating	45	45
Infusion or Flow Problem	44	44
Physical Resistance/Sticking	42	42
Unexpected Shutdown	42	42
Device Damaged Prior to Use	39	39
Crack	38	38
Use of Incorrect Control/Treatment Settings	36	36
Unintended Application Program Shut Down	35	35
Wireless Communication Problem	31	31
Fluid/Blood Leak	31	31
Inadequacy of Device Shape and/or Size	31	31
Unexpected Therapeutic Results	31	31
Loose or Intermittent Connection	29	29
Inflation Problem	28	28
Display or Visual Feedback Problem	25	25
Patient-Device Incompatibility	25	25
Failure to Read Input Signal	21	21
Temperature Problem	21	21
No Display/Image	20	20
Material Twisted/Bent	19	19
Excessive Heating	19	19
Device Emits Odor	17	17
Component Missing	17	17
Calibration Problem	17	17
Tear, Rip or Hole in Device Packaging	15	15
Peeled/Delaminated	15	15
Material Puncture/Hole	14	14
Failure of Device to Self-Test	14	14
Scratched Material	14	14
Protective Measures Problem	14	14
Material Split, Cut or Torn	14	14
Radiation Underexposure	13	13
Radiation Leak	13	13
Device Handling Problem	12	12
Gas/Air Leak	12	12
Unsealed Device Packaging	11	11
Loss of Power	11	11
Delivered as Unsterile Product	11	11
Circuit Failure	11	11
Burst Container or Vessel	11	11
Intermittent Continuity	10	10
Human-Device Interface Problem	10	10
Activation Problem	10	10
Separation Problem	9	9
Radiation Output Problem	9	9
Complete Loss of Power	9	9
Leak/Splash	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6843	7147
No Consequences Or Impact To Patient	2119	2119
No Known Impact Or Consequence To Patient	1622	1622
Insufficient Information	652	652
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	593	760
Burn(s)	431	431
Keratitis	280	281
Visual Impairment	175	175
Blurred Vision	145	145
Pain	123	123
Eye Injury	115	115
Hemorrhage/Bleeding	93	93
No Code Available	93	93
Visual Disturbances	80	80
No Patient Involvement	78	78
Scar Tissue	78	78
Tissue Damage	73	73
Foreign Body In Patient	65	65
Radiation Exposure, Unintended	62	62
Unspecified Tissue Injury	52	52
Superficial (First Degree) Burn	52	52
Blister	48	48
Hematuria	47	47
Urinary Retention	45	45
Muscle Weakness	40	40
Inflammation	40	40
Swelling/ Edema	40	40
Urinary Tract Infection	39	39
Device Embedded In Tissue or Plaque	38	38
Partial thickness (Second Degree) Burn	38	38
Stenosis	37	37
Patient Problem/Medical Problem	36	36
Eye Pain	36	36
Corneal Abrasion	35	35
Skin Discoloration	34	34
Erythema	33	33
Fever	33	33
Dysuria	33	33
Urinary Incontinence	30	30
Headache	30	30
Intracranial Hemorrhage	29	29
Unspecified Kidney or Urinary Problem	29	29
Foreign Body Sensation in Eye	28	28
Perforation	28	28
Unspecified Infection	28	28
Urethral Stenosis/Stricture	26	26
Discomfort	25	25
Hematoma	25	25
Dry Eye(s)	25	25
Red Eye(s)	24	24
Full thickness (Third Degree) Burn	24	24
Eye Infections	21	21
Urinary Frequency	21	21
Halo	21	21
Dysphasia	20	20
Convulsion/Seizure	20	20
Skin Inflammation/ Irritation	20	20
Unspecified Nervous System Problem	19	19
Memory Loss/Impairment	19	19
Nerve Damage	19	19
Paresis	19	19
Renal Failure	18	18
Micturition Urgency	18	18
Loss of Vision	17	17
Sepsis	16	16
Swelling	16	16
Corneal Clouding/Hazing	15	15
Edema	15	15
Corneal Perforation	15	15
Burning Sensation	15	15
Thrombosis/Thrombus	15	15
No Information	14	14
Scarring	14	14
Burn, Thermal	13	13
Cognitive Changes	12	12
Cerebral Edema	12	12
Hypersensitivity/Allergic reaction	12	12
Seizures	11	11
Retinal Injury	11	11
Bacterial Infection	11	11
Eye Burn	11	11
Post Operative Wound Infection	11	11
Numbness	10	10
Ambulation Difficulties	10	10
Neurological Deficit/Dysfunction	10	10
Nausea	9	9
Bruise/Contusion	9	9
Hydrocephalus	9	9
Impaired Healing	8	8
Radiation Burn	8	8
Corneal Edema	7	7
Hyperplasia	7	7
Laceration(s)	7	7
Injury	7	7
Dizziness	7	7
Depression	6	6
Complaint, Ill-Defined	6	6
Corneal Infiltrates	6	6
Obstruction/Occlusion	6	6
Skin Infection	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Accure Acne, Inc	II	Jan-20-2024
2	Advance-Esthetic LLC	II	Oct-13-2023
3	Aerolase Corporation	II	Jan-03-2020
4	Angiodynamics, Inc.	II	Sep-27-2022
5	Angiodynamics, Inc.	II	Aug-30-2019
6	Boston Scientific Corporation	II	Jul-21-2023
7	Boston Scientific Corporation	III	Jul-15-2022
8	Boston Scientific Corporation	II	Apr-24-2020
9	Boston Scientific Corporation	II	May-22-2019
10	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
11	Candela Corporation	II	Oct-24-2019
12	Clarus Medical, Llc	II	Sep-03-2021
13	Dornier Medtech America, Inc.	II	May-21-2019
14	Inova Lasers LLC	II	Nov-17-2020
15	Karl Storz Endoscopy	II	May-13-2024
16	Medtronic Navigation, Inc.	II	May-06-2020
17	Medtronic Sofamor Danek USA Inc	II	Jul-23-2020
18	Olympus Corporation of the Americas	II	Mar-27-2024
19	Olympus Corporation of the Americas	II	Jan-18-2024
20	Olympus Corporation of the Americas	II	Jan-12-2024
21	Olympus Corporation of the Americas	II	Jan-12-2024
22	Olympus Corporation of the Americas	II	Jun-28-2022
23	Olympus Corporation of the Americas	II	Aug-15-2021
24	Quanta System, S.p.A.	II	Jun-10-2021
25	Ra Medical Systems, Inc.	II	Apr-01-2020
26	Xintec Corp	III	Oct-18-2019