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	2
ADVALIGHT APS
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC TECHNOLOGY, LTD.
	SUBSTANTIALLY EQUIVALENT	2
ALLENGERS GLOBAL HEALTHCARE PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	2
ALMA LASERS , LTD.
	SUBSTANTIALLY EQUIVALENT	2
ALMA LASERS, INC.
	SUBSTANTIALLY EQUIVALENT	7
AMI, INC.
	SUBSTANTIALLY EQUIVALENT	1
AMT ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASCLEPION LASER TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	7
AVAVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
AVENDA HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
AZENA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BAODING TE'ANZHOU ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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	4
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	2
BEIJING WINKONLASER TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BELLAMIA TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIO-MED USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOLASE, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
BIOTEC ITALIA, SRL
	SUBSTANTIALLY EQUIVALENT	1
BLUECORE COMPANY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
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	2
CLASSYS, INC.
	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	3
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
DAWELL MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
EL.EN ELECTROINC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
EL.EN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	5
EL.EN S.P.A.
	SUBSTANTIALLY EQUIVALENT	8
ELESTA S.P.A
	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	2
GUANGZHOU POTENT MEDICAL EQUIPMENT JOINT-STOCK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
HEAGER GMBH
	SUBSTANTIALLY EQUIVALENT	1
HEBEI JT MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI KEYLASER SCI-TECH CO.,LTD
	SUBSTANTIALLY EQUIVALENT	3
HEBEI NEWANGIE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HEBEI ZHEMAI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HIGH TECHNOLOGY PRODUCTS S.L.U
	SUBSTANTIALLY EQUIVALENT	2
HIRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HULASER, INC.
	SUBSTANTIALLY EQUIVALENT	1
I.T.S. GROUP S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
IBRAMED EQUIPAMENTOS MÉDICOS
	SUBSTANTIALLY EQUIVALENT	1
IDS, LIMITED
	SUBSTANTIALLY EQUIVALENT	1
IDS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO,., LTD.
	SUBSTANTIALLY EQUIVALENT	5
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	2
IVYLASER (BEIJING) TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
JEISYS MEDICAL INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
JIANGXI MEDEX TECHNOLOGY CO., LTD.
	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, SLU
	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	4
LUMENIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS, LTD.
	SUBSTANTIALLY EQUIVALENT	5
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
LUVO MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
M&T S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
MATELASER, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDENCY S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL SAN INDÚSTRIA DE EQUIPAMENTOS MÉDICOS LTDA.
	SUBSTANTIALLY EQUIVALENT	2
MEDICO USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICREATIONS, LLC
	SUBSTANTIALLY EQUIVALENT	2
MEDMIX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEGABAY S.A.
	SUBSTANTIALLY EQUIVALENT	1
MENOVEX MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-ENERGY MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MONTERIS MEDICAL,
	SUBSTANTIALLY EQUIVALENT	3
MONTERIS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MVITRO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANJING BESTVIEW LASER S&T CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
PATRIOT LASER, LLC
	SUBSTANTIALLY EQUIVALENT	1
QUANTA SYSTEM SPA
	SUBSTANTIALLY EQUIVALENT	14
RAJA TRADING COMPANY, INC.
	SUBSTANTIALLY EQUIVALENT	2
REALTON (SUZHOU) MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
REVEAL LASERS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
RHEIN LASER TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
RISU MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ROHRER AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1
ROHRER AESTHETICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SANHE LASERCONN TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SANHE MEDITECH CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SANHE LEFIS ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SCITON, INC.
	SUBSTANTIALLY EQUIVALENT	2
SENBITEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	3
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMEDTRUM MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SNJ CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SOLAR LS CJSC
	SUBSTANTIALLY EQUIVALENT	1
SOLITON, INC.
	SUBSTANTIALLY EQUIVALENT	4
SOLTA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SOLTA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPECLIPSE., 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
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) 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	2
WONTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	17
WUHAN DIMED LASER TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WUHAN LOTUXS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WUHAN PIOON TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
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	2
ZHENGZHOU BESTVIEW ST CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
ZHUOLU JONTELASER MANUFACTURING TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHUOZHOU SUMMER STAR TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER MEDIZINSYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	2183	2194
2021	3465	3480
2022	2288	2755
2023	2337	2337
2024	2220	2252
2025	2571	2772

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3327	3329
Adverse Event Without Identified Device or Use Problem	2695	2872
Decrease in Suction	1378	1849
Defective Device	802	802
Firing Problem	639	639
Failure to Align	523	523
Device Displays Incorrect Message	519	519
Appropriate Term/Code Not Available	499	499
Fracture	472	476
Output Problem	339	341
Overheating of Device	329	334
Detachment of Device or Device Component	307	307
Output below Specifications	292	292
Therapeutic or Diagnostic Output Failure	283	287
Device Operational Issue	272	272
Smoking	247	247
Use of Device Problem	240	240
Mechanical Problem	228	233
Fire	228	229
Power Problem	220	220
Insufficient Information	196	197
Degraded	194	194
Connection Problem	192	192
Unexpected Therapeutic Results	160	160
Contamination	155	182
Failure to Fire	149	151
Thermal Decomposition of Device	137	141
No Apparent Adverse Event	119	119
Melted	107	108
Suction Problem	105	105
Communication or Transmission Problem	103	106
Loss of or Failure to Bond	100	100
Noise, Audible	98	98
Material Integrity Problem	95	95
Failure to Deliver Energy	95	95
Gas Output Problem	95	95
Computer Software Problem	86	86
Electrical /Electronic Property Problem	82	82
Optical Problem	77	77
Unexpected/Unintended Radiation Output	71	71
Device Contaminated During Manufacture or Shipping	70	70
Energy Output Problem	69	69
Failure to Power Up	67	67
Incorrect, Inadequate or Imprecise Result or Readings	66	66
Sparking	60	60
Improper or Incorrect Procedure or Method	60	60
Use of Incorrect Control/Treatment Settings	59	59
Suction Failure	57	57
Physical Resistance/Sticking	53	53
Unexpected Shutdown	50	50

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9496	9852
Insufficient Information	941	949
No Consequences Or Impact To Patient	909	909
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	651	831
No Known Impact Or Consequence To Patient	616	622
Burn(s)	496	496
Keratitis	275	276
Visual Impairment	158	161
Blurred Vision	146	149
Pain	141	144
Hemorrhage/Bleeding	141	141
Eye Injury	134	136
Urinary Retention	112	112
Hematuria	106	106
Foreign Body In Patient	94	94
Visual Disturbances	93	96
Scar Tissue	87	88
Blister	84	84
Unspecified Tissue Injury	75	75
Urinary Tract Infection	73	73
Urethral Stenosis/Stricture	70	70
Superficial (First Degree) Burn	60	60
Swelling/ Edema	59	59
Stenosis	58	222
Fever	54	54
Urinary Incontinence	54	54
Radiation Exposure, Unintended	53	53
Inflammation	51	51
Unspecified Infection	49	49
Partial thickness (Second Degree) Burn	48	49
Full thickness (Third Degree) Burn	47	47
Erythema	46	46
No Code Available	45	46
Perforation	43	43
Muscle Weakness	42	42
Skin Discoloration	38	38
Sepsis	38	38
Eye Pain	37	37
Intracranial Hemorrhage	37	37
Dysuria	37	37
No Patient Involvement	36	36
Corneal Abrasion	35	35
Unspecified Kidney or Urinary Problem	30	30
Micturition Urgency	30	30
Skin Inflammation/ Irritation	28	29
Foreign Body Sensation in Eye	28	28
Hematoma	28	28
Discomfort	28	28
Tissue Damage	27	27
Device Embedded In Tissue or Plaque	27	27

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	Aug-21-2025
13	LUMENIS, LTD.	II	Mar-05-2025
14	Medtronic Navigation, Inc.	II	May-06-2020
15	Medtronic Sofamor Danek USA Inc	II	Jul-23-2020
16	Olympus Corporation of the Americas	II	Jun-06-2025
17	Olympus Corporation of the Americas	II	May-01-2025
18	Olympus Corporation of the Americas	II	Oct-18-2024
19	Olympus Corporation of the Americas	II	Aug-05-2024
20	Olympus Corporation of the Americas	II	Mar-27-2024
21	Olympus Corporation of the Americas	II	Jan-18-2024
22	Olympus Corporation of the Americas	II	Jan-12-2024
23	Olympus Corporation of the Americas	II	Jan-12-2024
24	Olympus Corporation of the Americas	II	Jun-28-2022
25	Olympus Corporation of the Americas	II	Aug-15-2021
26	Quanta System, S.p.A.	II	Jun-10-2021
27	Ra Medical Systems, Inc.	II	Apr-01-2020
28	WINGDERM ELECTRO-OPTICS LTD.	II	Dec-05-2024