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
ACCLARO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ACCURE ACNE, INC
	SUBSTANTIALLY EQUIVALENT	1
ACCURE ACNE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVALIGHT APS
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC TECHNOLOGY LTD
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	1
ALLENGERS GLOBAL HEALTHCARE PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	2
ALMA LASERS INC.
	SUBSTANTIALLY EQUIVALENT	2
ALMA LASERS, INC
	SUBSTANTIALLY EQUIVALENT	1
ALMA LASERS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ALMA LASERS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
AMI INC.
	SUBSTANTIALLY EQUIVALENT	1
AMT ENGINEERING CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
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	3
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 MEGA BEAUTY TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING NUBWAY S&T CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING SANO LASER S&T DEVELOPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
BEIJING SANO LASER S&T DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING SANO LASER S&T DEVELOPMENT CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
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	2
BEIJING UNT TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BEIJING UNT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING WINKONLASER TECHNOLOGY LIMITED.
	SUBSTANTIALLY EQUIVALENT	1
BIO-MED USA INC
	SUBSTANTIALLY EQUIVALENT	2
BIOLASE, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOLASE, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
BIOTEC ITALIA, SRL
	SUBSTANTIALLY EQUIVALENT	1
BLUECORE COMPANY CO LTD
	SUBSTANTIALLY EQUIVALENT	1
BLUECORE COMPANY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BT BEAMEDICAL TACHNOOGIES LTD. (BEAMED)
	SUBSTANTIALLY EQUIVALENT	1
BTL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION (CPMT LASER)
	SUBSTANTIALLY EQUIVALENT	2
CANDELA CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
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	4
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	3
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 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	6
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
FABINJECT LNDUSTRIA E COMERCIO LMPORTACAO E EXPORTACAO LTDA
	SUBSTANTIALLY EQUIVALENT	1
FOTONA D.O.O.
	SUBSTANTIALLY EQUIVALENT	9
G.N.S NEOLASER LTD.
	SUBSTANTIALLY EQUIVALENT	1
GIGAALASER COMPANY LTD.
	SUBSTANTIALLY EQUIVALENT	2
GLOBAL MED SYSTEMS SL
	SUBSTANTIALLY EQUIVALENT	1
GME GERMAN MEDICAL ENGINEERING GMBH
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU CHUANG ZAO MEI TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU CHUANG ZAO MEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
HEBEI JT MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI KEYLASER SCI-TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI ZHEMAI TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
HIGH TECHNOLOGY PRODUCTS SLU
	SUBSTANTIALLY EQUIVALENT	2
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	2
ILOODA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INMODE LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
IVYLASER (BEIJING) TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	2
JIANGXI MEDEX TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI MEDEX TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
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
LIGHT GUIDE OPTICS INTERNATIONAL LTD.
	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	3
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	2
LUVO MEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	3
M&T S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
M&T SRL
	SUBSTANTIALLY EQUIVALENT	1
MATELASER, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDENCY S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL SAN INDÚSTRIA DE EQUIPAMENTOS MÉDICOS LTDA
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL SAN INDÚSTRIA DE EQUIPAMENTOS MÉDICOS LTDA.
	SUBSTANTIALLY EQUIVALENT	1
MEDICO USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICREATIONS LLC
	SUBSTANTIALLY EQUIVALENT	2
MEDMIX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEGABAY S.A.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-ENERGY MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MONTERIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
MONTERIS MEDICAL,
	SUBSTANTIALLY EQUIVALENT	1
MONTERIS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MVITRO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANJING BESTVIEW LASER S&T CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANOSPECTRA BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
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
QUANTA SYSTEM S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
QUANTA SYSTEM SPA
	SUBSTANTIALLY EQUIVALENT	12
QUANTA SYSTEM, S.P.A.
	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
REVEAL LASERS LTD.
	SUBSTANTIALLY EQUIVALENT	1
RHEIN LASER TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
RISU MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ROHRER AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1
ROHRER AESTHETICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SANHE LASERCONN TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SCITON, INC
	SUBSTANTIALLY EQUIVALENT	2
SENTIENT MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG MOONLIGHT ELECTRONICS TECH CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
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 LEAFLIFE TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMEDTRUM MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SNJ CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SNJ CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLAR LS CJSC
	SUBSTANTIALLY EQUIVALENT	1
SOLITON INC.
	SUBSTANTIALLY EQUIVALENT	4
SOLTA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
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	2
THERALASER MEDTECH (CHINA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TRIANGEL RSD LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VENUS CONCEPT USA INC.
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	2
W & R INVESTMENTS, LLC DBA LASER ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
WEIFANG DRAGONFLY ELECTRONICS TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WEIFANG MINGLIANG ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WEIFANG MINGLIANG ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WON TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	11
WONTECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WONTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
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	4
XEMIS MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUOZHOU SUMMER STAR TECHNOLOGIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER MEDIZINSYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	2182	2182
2021	3465	3465
2022	2288	2752
2023	2338	2338
2024	2220	2251
2025	1350	1515

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2940	2940
Adverse Event Without Identified Device or Use Problem	2459	2619
Decrease in Suction	1377	1847
Defective Device	728	728
Firing Problem	585	585
Failure to Align	515	515
Device Displays Incorrect Message	489	489
Appropriate Term/Code Not Available	480	480
Fracture	459	459
Output Problem	335	335
Overheating of Device	313	313
Detachment of Device or Device Component	296	296
Therapeutic or Diagnostic Output Failure	282	282
Device Operational Issue	269	269
Mechanical Problem	219	224
Use of Device Problem	210	210
Fire	209	209
Output below Specifications	208	208
Smoking	199	199
Degraded	192	192
Power Problem	192	192
Connection Problem	185	185
Insufficient Information	160	160
Failure to Fire	148	148
Contamination	144	157
Thermal Decomposition of Device	127	127
No Apparent Adverse Event	115	115
Unexpected Therapeutic Results	103	103
Melted	96	96
Failure to Deliver Energy	95	95
Loss of or Failure to Bond	95	95
Suction Problem	90	90
Gas Output Problem	88	88
Noise, Audible	85	85
Electrical /Electronic Property Problem	80	80
Communication or Transmission Problem	80	83
Material Integrity Problem	77	77
Optical Problem	74	74
Computer Software Problem	74	74
Device Contaminated During Manufacture or Shipping	69	69
Incorrect, Inadequate or Imprecise Result or Readings	64	64
Failure to Power Up	63	63
Energy Output Problem	62	62
Suction Failure	57	57
Unexpected/Unintended Radiation Output	56	56
Sparking	53	53
Improper or Incorrect Procedure or Method	52	52
Physical Resistance/Sticking	49	49
Material Separation	48	48
Use of Incorrect Control/Treatment Settings	47	47

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8605	8929
No Consequences Or Impact To Patient	909	909
Insufficient Information	863	863
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	637	813
No Known Impact Or Consequence To Patient	616	616
Burn(s)	432	432
Keratitis	270	271
Visual Impairment	151	154
Blurred Vision	146	149
Eye Injury	127	129
Hemorrhage/Bleeding	126	126
Pain	126	126
Visual Disturbances	91	94
Urinary Retention	88	88
Hematuria	87	87
Scar Tissue	82	82
Foreign Body In Patient	81	81
Unspecified Tissue Injury	72	72
Blister	65	65
Urinary Tract Infection	60	60
Urethral Stenosis/Stricture	59	59
Superficial (First Degree) Burn	57	57
Stenosis	56	206
Swelling/ Edema	54	54
Radiation Exposure, Unintended	53	53
Fever	49	49
Inflammation	47	47
Urinary Incontinence	46	46
No Code Available	45	45
Muscle Weakness	41	41
Perforation	40	40
Erythema	40	40
Eye Pain	37	37
Partial thickness (Second Degree) Burn	37	37
No Patient Involvement	36	36
Corneal Abrasion	35	35
Unspecified Infection	33	33
Dysuria	33	33
Intracranial Hemorrhage	32	32
Skin Discoloration	32	32
Unspecified Kidney or Urinary Problem	29	29
Sepsis	29	29
Foreign Body Sensation in Eye	28	28
Full thickness (Third Degree) Burn	28	28
Tissue Damage	27	27
Device Embedded In Tissue or Plaque	26	26
Discomfort	26	26
Hematoma	25	25
Headache	25	25
Micturition Urgency	24	24

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	Boston Scientific Corporation	II	Jul-21-2023
6	Boston Scientific Corporation	III	Jul-15-2022
7	Boston Scientific Corporation	II	Apr-24-2020
8	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
9	Clarus Medical, Llc	II	Sep-03-2021
10	Inova Lasers LLC	II	Nov-17-2020
11	Karl Storz Endoscopy	II	May-13-2024
12	LUMENIS, LTD.	II	Mar-05-2025
13	Medtronic Navigation, Inc.	II	May-06-2020
14	Medtronic Sofamor Danek USA Inc	II	Jul-23-2020
15	Olympus Corporation of the Americas	II	Jun-06-2025
16	Olympus Corporation of the Americas	II	May-01-2025
17	Olympus Corporation of the Americas	II	Oct-18-2024
18	Olympus Corporation of the Americas	II	Aug-05-2024
19	Olympus Corporation of the Americas	II	Mar-27-2024
20	Olympus Corporation of the Americas	II	Jan-18-2024
21	Olympus Corporation of the Americas	II	Jan-12-2024
22	Olympus Corporation of the Americas	II	Jan-12-2024
23	Olympus Corporation of the Americas	II	Jun-28-2022
24	Olympus Corporation of the Americas	II	Aug-15-2021
25	Quanta System, S.p.A.	II	Jun-10-2021
26	Ra Medical Systems, Inc.	II	Apr-01-2020
27	WINGDERM ELECTRO-OPTICS LTD.	II	Dec-05-2024