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
ACCURE ACNE, INC.
	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	3
ALMA LASERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALMA LASERS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
AMI INC.
	SUBSTANTIALLY EQUIVALENT	1
AMT ENGINEERING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ASCLEPION LASER TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	3
AVAVA, INC
	SUBSTANTIALLY EQUIVALENT	1
AVENDA HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
AZENA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BEIJING ADSS DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	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
BIO-MED USA INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOLASE, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOLASE, INC.
	SUBSTANTIALLY EQUIVALENT	3
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
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT	1
CONVERGENT LASER TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
CUTERA, INC.
	SUBSTANTIALLY EQUIVALENT	3
CYNOSURE LLC
	SUBSTANTIALLY EQUIVALENT	2
CYNOSURE, INC
	SUBSTANTIALLY EQUIVALENT	1
D.E.A PROJECT S.R.1.
	SUBSTANTIALLY EQUIVALENT	1
DAEJU MEDITECH ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA
	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 S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
EL.EN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	5
EL.EN. ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
ELEMENIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELEN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
ELESTA SPA
	SUBSTANTIALLY EQUIVALENT	2
ELLIPSE A/S
	SUBSTANTIALLY EQUIVALENT	2
ENDYMED MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
EPILADY 2000 LLC
	SUBSTANTIALLY EQUIVALENT	1
FA INTERNATIONAL, LP
	SUBSTANTIALLY EQUIVALENT	1
FINEMEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FORMATK SYSTEMS LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOTONA D.O.O.
	SUBSTANTIALLY EQUIVALENT	10
GLOBAL MED SYSTEMS SL
	SUBSTANTIALLY EQUIVALENT	1
GME GERMAN MEDICAL ENGINEERING GMBH
	SUBSTANTIALLY EQUIVALENT	4
GUANGZHOU CHUANG ZAO MEI TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU HUAFEI TONGDA 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	2
HULASER, INC.
	SUBSTANTIALLY EQUIVALENT	1
I.T.S. GROUP S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
IDS, LIMITED
	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
INMODE MD LTD.
	SUBSTANTIALLY EQUIVALENT	2
INNOVAQUARTZ LLC
	SUBSTANTIALLY EQUIVALENT	2
INNOVOYCE LLC
	SUBSTANTIALLY EQUIVALENT	1
IRIDEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	2
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
LAMEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LASER ENGINEERING, INC.
	SUBSTANTIALLY EQUIVALENT	1
LASEROPTEK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	8
LAZON MEDICAL LASER CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LEASEIR TECHNOLOGIES S.L.U.
	SUBSTANTIALLY EQUIVALENT	1
LEONI FIBER OPTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSCALPEL INC
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSCALPEL LLC
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSENSE TECHNOLOGIES LTD
	SUBSTANTIALLY EQUIVALENT	1
LISA LASER PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
LITECURE, LLC
	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	5
LUMENIS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
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
MILLENNIUM DENTAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MONTERIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
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	1
OMNIGUIDE, INC.
	SUBSTANTIALLY EQUIVALENT	2
QUANTA SYSTEM SPA
	SUBSTANTIALLY EQUIVALENT	16
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
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	4
SCITON, INC.
	SUBSTANTIALLY EQUIVALENT	1
SENTIENT MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
SHANGHAI OMNI LASER SKINOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., 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	2
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
STEP UP SKIN LASER, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRATA SKIN SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
SYNERON-CANDELA
	SUBSTANTIALLY EQUIVALENT	1
SYNERON-CANDELA CORP
	SUBSTANTIALLY EQUIVALENT	1
TERMOSALUD
	SUBSTANTIALLY EQUIVALENT	1
TRIANGEL RSD LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VENUS CONCEPT USA INC.
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	4
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	8
WONTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN DIMED LASER TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN LOTUXS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN PIOON TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN PIOON TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZELTIQ AESTHETICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZHENGZHOU BESTVIEW ST CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
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
2018	3525	3525
2019	2709	2709
2020	2182	2182
2021	3465	3465
2022	2288	2752
2023	2132	2132

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3580	3580
Adverse Event Without Identified Device or Use Problem	2368	2368
Fracture	1672	1672
Decrease in Suction	1358	1822
Appropriate Term/Code Not Available	932	932
Temperature Problem	750	750
Detachment of Device or Device Component	679	679
Defective Device	571	571
Therapeutic or Diagnostic Output Failure	449	449
Firing Problem	429	429
Output Problem	365	365
Overheating of Device	348	348
Device Displays Incorrect Message	347	347
Device Operational Issue	253	253
Failure to Align	251	251
Mechanical Problem	237	237
Degraded	234	234
Suction Problem	221	221
Insufficient Information	197	197
Failure to Fire	163	163
Use of Device Problem	161	161
Connection Problem	152	152
Computer Software Problem	151	151
Fire	141	141
Device Operates Differently Than Expected	140	140
Power Problem	138	138
Misfire	129	129
Unexpected Therapeutic Results	124	124
Contamination	119	119
Failure to Deliver Energy	116	116
No Apparent Adverse Event	116	116
Material Integrity Problem	102	102
Smoking	100	100
Thermal Decomposition of Device	99	99
Suction Failure	99	99
Crack	96	96
Electrical /Electronic Property Problem	96	96
Failure to Cut	94	94
Optical Problem	88	88
Loss of or Failure to Bond	87	87
Energy Output Problem	86	86
Incorrect, Inadequate or Imprecise Result or Readings	82	82
Melted	80	80
Output below Specifications	78	78
Gas Output Problem	71	71
Improper or Incorrect Procedure or Method	68	68
Device Contaminated During Manufacture or Shipping	66	66
Material Deformation	65	65
Material Fragmentation	58	58
Insufficient Heating	57	57
Material Separation	55	55
Defective Component	54	54
No Device Output	50	50
Noise, Audible	49	49
Communication or Transmission Problem	48	48
Failure to Power Up	48	48
Detachment Of Device Component	46	46
Infusion or Flow Problem	45	45
Physical Resistance/Sticking	44	44
Unexpected Shutdown	43	43
Unexpected/Unintended Radiation Output	41	41
Protective Measures Problem	39	39
Sparking	38	38
Inflation Problem	35	35
Patient-Device Incompatibility	35	35
Inadequacy of Device Shape and/or Size	34	34
Use of Incorrect Control/Treatment Settings	32	32
Fluid/Blood Leak	31	31
Loose or Intermittent Connection	31	31
Device Damaged Prior to Use	30	30
Display or Visual Feedback Problem	29	29
Gas/Air Leak	27	27
Material Twisted/Bent	24	24
Device Inoperable	24	24
Wireless Communication Problem	23	23
Calibration Problem	22	22
Device Emits Odor	22	22
Unintended Application Program Shut Down	21	21
Peeled/Delaminated	20	20
Failure to Read Input Signal	19	19
No Display/Image	19	19
Excessive Heating	19	19
Failure of Device to Self-Test	17	17
Material Split, Cut or Torn	16	16
Leak/Splash	16	16
Component Missing	16	16
Material Puncture/Hole	16	16
Loss of Power	16	16
Tear, Rip or Hole in Device Packaging	15	15
Scratched Material	15	15
Human-Device Interface Problem	12	12
Radiation Underexposure	11	11
Device Handling Problem	11	11
Activation Problem	11	11
Difficult to Remove	11	11
Radiation Leak	11	11
Circuit Failure	11	11
Burst Container or Vessel	11	11
Delivered as Unsterile Product	10	10
Unsealed Device Packaging	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5899	6197
No Consequences Or Impact To Patient	3551	3551
No Known Impact Or Consequence To Patient	3030	3030
Insufficient Information	601	601
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	522	688
Burn(s)	483	483
Keratitis	379	379
Visual Impairment	199	199
No Code Available	196	197
Blurred Vision	152	152
Pain	144	145
No Patient Involvement	122	122
Eye Injury	97	97
Hemorrhage/Bleeding	93	93
Visual Disturbances	87	87
Tissue Damage	82	82
Foreign Body In Patient	73	73
Radiation Exposure, Unintended	70	70
Scar Tissue	68	68
Partial thickness (Second Degree) Burn	59	59
Superficial (First Degree) Burn	57	57
Patient Problem/Medical Problem	51	51
Urinary Retention	51	51
Urinary Tract Infection	51	51
Device Embedded In Tissue or Plaque	49	49
Hematuria	48	48
Inflammation	45	45
Stenosis	44	44
Headache	42	42
Muscle Weakness	41	41
Dysuria	39	39
Skin Discoloration	38	38
Corneal Abrasion	36	36
No Information	36	36
Eye Pain	36	36
Blister	36	36
Unspecified Tissue Injury	33	33
Discomfort	33	33
Swelling/ Edema	32	32
Fever	32	32
Foreign Body Sensation in Eye	30	30
Perforation	30	30
Unspecified Infection	30	30
Dry Eye(s)	29	29
Erythema	28	28
Memory Loss/Impairment	28	28
Intracranial Hemorrhage	28	28
Burning Sensation	28	28
Unspecified Kidney or Urinary Problem	27	27
Swelling	26	26
Hematoma	26	26
Burn, Thermal	25	25
Urinary Frequency	24	24
Red Eye(s)	24	24
Paresis	24	24
Dysphasia	23	23
Urethral Stenosis/Stricture	23	23
Full thickness (Third Degree) Burn	22	22
Halo	22	22
Nerve Damage	22	22
Scarring	21	21
Seizures	21	21
Eye Infections	21	21
Urinary Incontinence	21	21
Edema	20	20
Incontinence	19	19
Convulsion/Seizure	19	19
Neurological Deficit/Dysfunction	18	18
Renal Failure	17	17
Corneal Clouding/Hazing	17	17
Micturition Urgency	16	16
Unspecified Nervous System Problem	16	16
Skin Inflammation/ Irritation	16	16
Blood Loss	16	16
Sepsis	15	15
Hypersensitivity/Allergic reaction	15	15
Ambulation Difficulties	14	14
Complaint, Ill-Defined	14	14
Injury	14	14
Cognitive Changes	13	13
Hydrocephalus	13	13
Thrombus	13	13
Corneal Perforation	13	13
Bacterial Infection	12	12
Cerebral Edema	12	12
Thrombosis/Thrombus	12	12
Post Operative Wound Infection	12	12
Loss of Vision	12	12
Weakness	11	11
Irritation	11	11
Nausea	11	11
Therapeutic Effects, Unexpected	10	10
Bruise/Contusion	10	10
Numbness	10	10
Depression	9	9
Death	9	9
Corneal Edema	8	8
Radiation Burn	8	8
Vomiting	8	8
Corneal Infiltrates	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Advance-Esthetic LLC	II	Oct-13-2023
2	Aerolase Corporation	II	Jan-03-2020
3	Angiodynamics, Inc.	II	Sep-27-2022
4	Angiodynamics, Inc.	II	Aug-30-2019
5	Beijing Syntech Laser Co., Ltd	II	May-02-2018
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	Boston Scientific Corporation	II	Mar-05-2018
11	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
12	Candela Corporation	II	Oct-24-2019
13	Clarus Medical, Llc	II	Sep-03-2021
14	Dornier Medtech America, Inc.	II	May-21-2019
15	Inova Lasers LLC	II	Nov-17-2020
16	Iridex Corporation	II	Mar-16-2018
17	Leoni Fiber Optics GmbH	II	Dec-07-2018
18	Medtronic Navigation, Inc.	II	May-06-2020
19	Medtronic Navigation, Inc.	II	Jul-19-2018
20	Medtronic Sofamor Danek USA Inc	II	Jul-23-2020
21	Monteris Medical Corp	I	Mar-20-2018
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