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	1
ACCLARO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ACCURE ACNE, INC.
	SUBSTANTIALLY EQUIVALENT	2
ADVALIGHT APS
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC TECHNOLOGY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	6
AVAVA, INC.
	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	3
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING LASERTELL MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	3
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	1
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	1
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
BIOTEC ITALIA, SRL
	SUBSTANTIALLY EQUIVALENT	1
BLUECORE COMPANY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON AESTHETICS, INC.
	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	2
C.R. BARD, 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	3
CAO GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	2
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	3
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	6
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	5
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
HAIDARI BEAUTY TECHNOLOGY (BEIJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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
HIRONIC CO., LTD.
	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	6
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	1
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
LUVO MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
M&T S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
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	2
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
ORO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PATRIOT LASER, LLC
	SUBSTANTIALLY EQUIVALENT	1
QUANTA SYSTEM SPA
	SUBSTANTIALLY EQUIVALENT	9
RAJA TRADING COMPANY, INC.
	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	2
ROHRER AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1
ROHRER AESTHETICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SANHE LASERCONN TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SANHE MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SANHE LEFIS ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SCITON, INC
	SUBSTANTIALLY EQUIVALENT	3
SENBITEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SENTIENT MANUFACTURING , LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG MOONLIGHT ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
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	3
SOLTA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SOLTA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPECLIPSE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SQUALUS MED , LTD.
	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
VYDENCE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	2
VYDENCE MEDICAL INDUSTRIA E COMMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	1
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
WINGDERM ELECTRO-OPTICS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
WONTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	16
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
XI'AN TAIBO ELECTRONIC TECHNOLOGY 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	1
ZHUOZHOU SUMMER STAR TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER MEDIZINSYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	3465	3480
2022	2288	2755
2023	2337	2337
2024	2220	2252
2025	2793	2994
2026	657	749

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3122	3124
Adverse Event Without Identified Device or Use Problem	2460	2716
Decrease in Suction	1360	1835
Defective Device	757	757
Firing Problem	675	675
Failure to Align	548	548
Device Displays Incorrect Message	500	500
Output below Specifications	360	360
Output Problem	316	317
Overheating of Device	287	291
Appropriate Term/Code Not Available	277	282
Smoking	269	269
Fire	241	242
Power Problem	239	239
Device Operational Issue	237	237
Unexpected Therapeutic Results	234	234
Use of Device Problem	230	233
Fracture	229	233
Detachment of Device or Device Component	201	201
Nonstandard Device	200	200
Mechanical Problem	197	202
Insufficient Information	195	196
Connection Problem	190	190
Contamination	157	184
Communication or Transmission Problem	145	148
Degraded	143	143
Material Integrity Problem	141	141
Thermal Decomposition of Device	136	139
Failure to Fire	126	128
Noise, Audible	114	114
No Apparent Adverse Event	105	105
Melted	103	104
Loss of or Failure to Bond	100	100
Gas Output Problem	100	100
Suction Problem	94	94
Therapeutic or Diagnostic Output Failure	81	83
Failure to Power Up	76	76
Use of Incorrect Control/Treatment Settings	75	75
Device Contaminated During Manufacture or Shipping	70	70
Electrical /Electronic Property Problem	67	67
Energy Output Problem	65	65
Sparking	64	64
Improper or Incorrect Procedure or Method	63	63
Unexpected/Unintended Radiation Output	62	62
Optical Problem	60	60
Failure to Deliver Energy	56	56
Physical Resistance/Sticking	55	55
Unexpected Shutdown	54	54
Incorrect, Inadequate or Imprecise Result or Readings	51	51
Device Damaged Prior to Use	46	46

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9859	10218
Insufficient Information	948	956
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	644	831
Burn(s)	485	485
Keratitis	219	220
Eye Injury	155	157
Hemorrhage/Bleeding	144	223
Pain	137	139
Blurred Vision	136	139
Visual Impairment	116	119
Urinary Retention	109	109
Hematuria	108	187
Foreign Body In Patient	91	91
Scar Tissue	86	87
Blister	85	85
Urinary Tract Infection	80	159
Visual Disturbances	77	80
Unspecified Tissue Injury	72	72
Urethral Stenosis/Stricture	70	149
Superficial (First Degree) Burn	67	67
Urinary Incontinence	62	62
Stenosis	58	301
Swelling/ Edema	57	57
Fever	54	54
No Consequences Or Impact To Patient	53	53
Full thickness (Third Degree) Burn	50	50
Partial thickness (Second Degree) Burn	50	51
Inflammation	47	47
Unspecified Infection	46	46
Erythema	43	43
Perforation	42	42
Corneal Abrasion	39	40
Skin Discoloration	38	38
Sepsis	38	38
Eye Pain	37	37
Muscle Weakness	35	35
Dysuria	35	35
Skin Inflammation/ Irritation	33	34
Micturition Urgency	32	32
Unspecified Kidney or Urinary Problem	30	30
Intracranial Hemorrhage	28	28
Corneal Perforation	28	28
Foreign Body Sensation in Eye	26	26
Hematoma	24	24
Red Eye(s)	24	24
Discomfort	24	24
Renal Failure	23	23
Unspecified Nervous System Problem	23	23
Eye Infections	22	22
Dysphasia	22	22

Recalls
Manufacturer		Recall Class	Date Posted
1	Accure Acne, Inc	II	Jan-20-2024
2	Advance-Esthetic LLC	II	Oct-13-2023
3	Angiodynamics, Inc.	II	Sep-27-2022
4	Boston Scientific Corporation	II	Jul-21-2023
5	Boston Scientific Corporation	III	Jul-15-2022
6	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
7	Clarus Medical, Llc	II	Sep-03-2021
8	Karl Storz Endoscopy	II	May-13-2024
9	LEASEIR TECHNOLOGIES SLU	II	Jan-16-2026
10	LUMENIS, LTD.	II	Aug-21-2025
11	LUMENIS, LTD.	II	Mar-05-2025
12	Lutronic Corporation	II	Mar-12-2026
13	Olympus Corporation of the Americas	II	Mar-30-2026
14	Olympus Corporation of the Americas	II	Jun-06-2025
15	Olympus Corporation of the Americas	II	May-01-2025
16	Olympus Corporation of the Americas	II	Oct-18-2024
17	Olympus Corporation of the Americas	II	Aug-05-2024
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	WINGDERM ELECTRO-OPTICS LTD.	II	Dec-05-2024