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
ACCLARO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ACCURE ACNE, INC
	SUBSTANTIALLY EQUIVALENT	1
ACCURE ACNE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC TECHNOLOGY LTD
	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	2
ALMA LASERS, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	2
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 SANO LASER S&T DEVELOPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
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	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	3
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
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
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
CONVERGENT LASER TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CPMT LASER (CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION)
	SUBSTANTIALLY EQUIVALENT	1
CUTERA, INC.
	SUBSTANTIALLY EQUIVALENT	3
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	2
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. ELECTRONIC ENGINEERING SPA
	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	5
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	10
GLOBAL MED SYSTEMS SL
	SUBSTANTIALLY EQUIVALENT	1
GME GERMAN MEDICAL ENGINEERING GMBH
	SUBSTANTIALLY EQUIVALENT	3
GUANGZHOU CHUANG ZAO MEI TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
HEBEI KEYLASER SCI-TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI ZHEMAI TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
HIGH TECHNOLOGY PRODUCTS SLU
	SUBSTANTIALLY EQUIVALENT	3
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	1
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
JEISYS MEDICAL INC
	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 S.L.U.
	SUBSTANTIALLY EQUIVALENT	1
LEONI FIBER OPTICS, INC.
	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	2
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	3
LUTRONIC GLOBAL
	SUBSTANTIALLY EQUIVALENT	1
LUVO MEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	3
M&T S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
M&T SRL
	SUBSTANTIALLY EQUIVALENT	2
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
MILLENNIUM DENTAL TECHNOLOGIES, INC.
	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
NANOSPECTRA BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEAUVIA NORTH AMERICA
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	2
OMNI-GUIDE HOLDINGS, INC.
	SUBSTANTIALLY EQUIVALENT	2
OMNIGUIDE, INC.
	SUBSTANTIALLY EQUIVALENT	2
QUANTA SYSTEM S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
QUANTA SYSTEM SPA
	SUBSTANTIALLY EQUIVALENT	11
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
RHEIN LASER TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
ROHRER AESTHETICS
	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	3
SENTIENT MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
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 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	3
SNJ CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SNJ CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLITON INC.
	SUBSTANTIALLY EQUIVALENT	5
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 INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	3
W & R INVESTMENTS, LLC DBA LASER ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
WEIFANG DRAGONFLY ELECTRONICS TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WEIFANG KM ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WEIFANG MINGLIANG 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	11
WONTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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	3
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
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
2019	2709	2709
2020	2182	2182
2021	3465	3465
2022	2288	2752
2023	2339	2339
2024	2017	2042

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3153	3153
Adverse Event Without Identified Device or Use Problem	2406	2414
Decrease in Suction	1375	1842
Fracture	899	899
Defective Device	666	666
Appropriate Term/Code Not Available	639	639
Firing Problem	529	529
Failure to Align	474	474
Detachment of Device or Device Component	462	462
Therapeutic or Diagnostic Output Failure	445	445
Device Displays Incorrect Message	405	405
Output Problem	364	364
Overheating of Device	344	344
Device Operational Issue	260	260
Mechanical Problem	247	247
Degraded	231	231
Use of Device Problem	194	194
Connection Problem	190	190
Fire	187	187
Failure to Fire	178	178
Insufficient Information	173	173
Power Problem	168	168
Output below Specifications	151	151
Contamination	141	149
Computer Software Problem	137	137
Smoking	136	136
No Apparent Adverse Event	132	132
Suction Problem	116	116
Thermal Decomposition of Device	115	115
Failure to Deliver Energy	112	112
Misfire	94	94
Optical Problem	92	92
Suction Failure	91	91
Loss of or Failure to Bond	91	91
Melted	89	89
Electrical /Electronic Property Problem	88	88
Incorrect, Inadequate or Imprecise Result or Readings	83	83
Gas Output Problem	83	83
Energy Output Problem	74	74
Material Integrity Problem	73	73
Device Contaminated During Manufacture or Shipping	68	68
Failure to Cut	67	67
Improper or Incorrect Procedure or Method	66	66
Communication or Transmission Problem	64	64
Noise, Audible	61	61
Unexpected/Unintended Radiation Output	55	55
Failure to Power Up	54	54
Material Deformation	52	52
Material Separation	51	51
Unexpected Shutdown	50	50

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7545	7856
No Consequences Or Impact To Patient	2119	2119
No Known Impact Or Consequence To Patient	1622	1622
Insufficient Information	736	736
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	607	777
Burn(s)	457	457
Keratitis	283	284
Visual Impairment	177	180
Blurred Vision	148	151
Pain	131	131
Eye Injury	121	121
Hemorrhage/Bleeding	108	108
No Code Available	93	93
Visual Disturbances	85	88
Scar Tissue	82	82
No Patient Involvement	78	78
Tissue Damage	73	73
Foreign Body In Patient	70	70
Radiation Exposure, Unintended	62	62
Unspecified Tissue Injury	58	58
Hematuria	57	57
Superficial (First Degree) Burn	56	56
Blister	55	55
Urinary Retention	54	54
Swelling/ Edema	48	48
Urinary Tract Infection	46	46
Stenosis	43	43
Inflammation	43	43
Muscle Weakness	41	41
Skin Discoloration	40	40
Partial thickness (Second Degree) Burn	40	40
Device Embedded In Tissue or Plaque	38	38
Erythema	37	37
Eye Pain	36	36
Urethral Stenosis/Stricture	36	36
Patient Problem/Medical Problem	36	36
Fever	36	36
Urinary Incontinence	36	36
Dysuria	35	35
Corneal Abrasion	35	35
Intracranial Hemorrhage	30	30
Headache	30	30
Unspecified Infection	29	29
Perforation	29	29
Unspecified Kidney or Urinary Problem	29	29
Foreign Body Sensation in Eye	28	28
Full thickness (Third Degree) Burn	28	28
Discomfort	26	26
Hematoma	25	25
Dry Eye(s)	25	25

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	Angiodynamics, Inc.	II	Aug-30-2019
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	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
11	Candela Corporation	II	Oct-24-2019
12	Clarus Medical, Llc	II	Sep-03-2021
13	Dornier Medtech America, Inc.	II	May-21-2019
14	Inova Lasers LLC	II	Nov-17-2020
15	Karl Storz Endoscopy	II	May-13-2024
16	Medtronic Navigation, Inc.	II	May-06-2020
17	Medtronic Sofamor Danek USA Inc	II	Jul-23-2020
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
29	Xintec Corp	III	Oct-18-2019