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	7
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	2
BEIJING NUBWAY S&T CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
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	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	3
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
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	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
DDC TECHNOLOGIES, INC.
	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	4
EMOLED, SRL
	SUBSTANTIALLY EQUIVALENT	1
ENAMEL PURE
	SUBSTANTIALLY EQUIVALENT	2
ENDYMED MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
EPILADY 2000, LLC
	SUBSTANTIALLY EQUIVALENT	2
EUFOTON S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
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
HEBEI ZOLLVAN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	2
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	3
MONTERIS MEDICAL,
	SUBSTANTIALLY EQUIVALENT	2
MVITRO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANJING BESTVIEW LASER S&T CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
NANOSPECTRA BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
NEAUVIA NORTH AMERICA
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	2
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	4
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	3
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	3
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	3
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	2
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	7
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	6
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	1912	2415

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3327	3329
Adverse Event Without Identified Device or Use Problem	2510	3153
Decrease in Suction	1357	1841
Firing Problem	725	725
Defective Device	709	709
Failure to Align	583	583
Device Displays Incorrect Message	495	495
Output below Specifications	464	464
Nonstandard Device	443	443
Overheating of Device	306	306
Unexpected Therapeutic Results	301	301
Smoking	296	296
Appropriate Device Problem Term/Code Not Available	293	317
Output Problem	289	289
Power Problem	275	275
Fire	241	241
Device Operational Issue	239	239
Fracture	232	232
Use of Device Problem	224	227
Detachment of Device or Device Component	217	217
Material Integrity Problem	212	212
Insufficient Device Problem Information	210	211
Mechanical Problem	208	213
Communication or Transmission Problem	204	207
Connection Problem	195	195
Contamination	162	189
Degraded	146	146
Thermal Decomposition of Device	130	131
Failure to Fire	126	126
Noise, Audible	118	128
No Apparent Adverse Event	110	110
Gas Output Problem	107	107
Suction Problem	104	104
Loss of or Failure to Bond	103	103
Melted	102	102
Use of Incorrect Control/Treatment Settings	92	92
Failure to Power Up	89	89
Sparking	81	81
Device Contaminated During Manufacture or Shipping	79	79
Unexpected Shutdown	74	74
Unexpected/Unintended Radiation Output	73	73
Electrical /Electronic Property Problem	70	70
Physical Resistance/Sticking	68	68
Improper or Incorrect Procedure or Method	67	67
Optical Problem	67	67
Failure to Deliver Energy	56	56
Incorrect, Inadequate or Imprecise Result or Readings	54	54
Energy Output Problem	50	50
Separation Problem	50	50
Wireless Communication Problem	44	44

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10818	11187
Insufficient Information	1012	1020
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	669	888
Burn(s)	536	536
Keratitis	238	240
Eye Injury	173	177
Hemorrhage/Blood Loss/Bleeding	164	243
Pain	139	141
Blurred Vision	136	139
Urinary Retention	123	123
Visual Impairment	119	122
Hematuria	118	197
Foreign Body In Patient	101	101
Blister	98	98
Scar Tissue	97	98
Urinary Tract Infection	93	172
Unspecified Tissue Injury	83	83
Urethral Stenosis/Stricture	82	161
Visual Disturbances	78	81
Urinary Incontinence	75	75
Superficial (First Degree) Burn	72	72
Stenosis	64	307
Full thickness (Third Degree) Burn	59	59
Swelling/ Edema	59	59
Fever	57	57
No Consequences Or Impact To Patient	53	53
Partial thickness (Second Degree) Burn	53	54
Perforation	50	50
Inflammation	48	48
Unspecified Infection	46	46
Corneal Abrasion	46	57
Erythema	45	45
Sepsis	43	43
Dysuria	39	39
Skin Discoloration	38	38
Eye Pain	37	37
Micturition Urgency	37	37
Skin Inflammation/ Irritation	35	36
Muscle Weakness/Atrophy	35	35
Corneal Perforation	34	34
Intracranial Hemorrhage	31	31
Unspecified Kidney or Urinary Problem	30	30
Hypopigmentation	27	27
Hyperpigmentation	26	26
Foreign Body Sensation in Eye	26	26
Unspecified Nervous System Problem	25	25
Hematoma	25	25
Renal Failure	25	25
Discomfort	25	25
Red Eye(s)	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	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	IPG Medical Corporation	II	Jun-24-2026
9	Karl Storz Endoscopy	II	May-13-2024
10	LEASEIR TECHNOLOGIES SLU	II	Jan-16-2026
11	LUMENIS, LTD.	II	Aug-21-2025
12	LUMENIS, LTD.	II	Mar-05-2025
13	Lutronic Corporation	II	Sep-04-2026
14	Lutronic Corporation	II	Mar-12-2026
15	Olympus Corporation of the Americas	II	Mar-30-2026
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	WINGDERM ELECTRO-OPTICS LTD.	II	Dec-05-2024