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
ACCURE ACNE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	1
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALMA LASERS INC.
	SUBSTANTIALLY EQUIVALENT	3
ALMA LASERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALMA LASERS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
AMI INC.
	SUBSTANTIALLY EQUIVALENT	1
AMT ENGINEERING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASCLEPION LASER TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	3
AVAVA, INC
	SUBSTANTIALLY EQUIVALENT	1
AVENDA HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
AZENA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BEIJING ADSS DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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 SANO LASER S&T DEVELOPMENT 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
BIO-MED USA INC
	SUBSTANTIALLY EQUIVALENT	2
BIO-MED USA INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOLASE, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOLASE, INC.
	SUBSTANTIALLY EQUIVALENT	3
BIOTEC ITALIA, SRL
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC
	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	4
CAO GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	3
CERAMOPTEC GMBH
	SUBSTANTIALLY EQUIVALENT	1
CLINICAL LASERTHERMIA SYSTEMS, AB
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT	1
CONVERGENT LASER TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
CUTERA, INC.
	SUBSTANTIALLY EQUIVALENT	2
CYNOSURE LLC
	SUBSTANTIALLY EQUIVALENT	2
CYNOSURE, INC
	SUBSTANTIALLY EQUIVALENT	1
D.E.A PROJECT S.R.1.
	SUBSTANTIALLY EQUIVALENT	1
DAEJU MEDITECH ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	1
DOMINION AESTHETIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA
	SUBSTANTIALLY EQUIVALENT	1
DORNIERMEDTECH AMERICA, INC
	SUBSTANTIALLY EQUIVALENT	1
EL. EN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
EL..EN. ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
EL.EN ELECTRONIC ENGINEERING S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
EL.EN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	5
EL.EN. ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
ELEMENIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELEN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
ELESTA SPA
	SUBSTANTIALLY EQUIVALENT	2
ELLIPSE A/S
	SUBSTANTIALLY EQUIVALENT	2
ENDYMED MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
EPILADY 2000 LLC
	SUBSTANTIALLY EQUIVALENT	1
FA INTERNATIONAL, LP
	SUBSTANTIALLY EQUIVALENT	1
FINEMEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FORMATK SYSTEMS LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOTONA D.O.O.
	SUBSTANTIALLY EQUIVALENT	10
GLOBAL MED SYSTEMS SL
	SUBSTANTIALLY EQUIVALENT	1
GME GERMAN MEDICAL ENGINEERING GMBH
	SUBSTANTIALLY EQUIVALENT	4
GUANGZHOU CHUANG ZAO MEI TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU HUAFEI TONGDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
HIGH TECHNOLOGY PRODUCTS SLU
	SUBSTANTIALLY EQUIVALENT	3
HIRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HULASER, INC.
	SUBSTANTIALLY EQUIVALENT	1
I.T.S. GROUP S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
IDS, LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO LTD
	SUBSTANTIALLY EQUIVALENT	2
ILOODA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INMODE LTD.
	SUBSTANTIALLY EQUIVALENT	1
INMODE MD LTD.
	SUBSTANTIALLY EQUIVALENT	2
INNOVAQUARTZ LLC
	SUBSTANTIALLY EQUIVALENT	2
INNOVOYCE LLC
	SUBSTANTIALLY EQUIVALENT	1
IRIDEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	2
LAMEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LASER ENGINEERING, INC.
	SUBSTANTIALLY EQUIVALENT	1
LASEROPTEK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	8
LAZON MEDICAL LASER CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LEASEIR TECHNOLOGIES S.L.U.
	SUBSTANTIALLY EQUIVALENT	1
LEONI FIBER OPTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSCALPEL INC
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSCALPEL LLC
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSENSE TECHNOLOGIES LTD
	SUBSTANTIALLY EQUIVALENT	1
LISA LASER PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
LITECURE, LLC
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS BE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS INC.
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS LTD.
	SUBSTANTIALLY EQUIVALENT	5
LUMENIS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
LUTRONIC GLOBAL
	SUBSTANTIALLY EQUIVALENT	1
LUVO MEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	3
M&T SRL
	SUBSTANTIALLY EQUIVALENT	2
MEDICO USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDMIX CO., LTD.
	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
NANOSPECTRA BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEAUVIA NORTH AMERICA
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	1
OMNI-GUIDE HOLDINGS, INC.
	SUBSTANTIALLY EQUIVALENT	2
OMNIGUIDE, INC
	SUBSTANTIALLY EQUIVALENT	1
OMNIGUIDE, INC.
	SUBSTANTIALLY EQUIVALENT	2
QUANTA SYSTEM SPA
	SUBSTANTIALLY EQUIVALENT	15
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
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	4
SCITON, INC.
	SUBSTANTIALLY EQUIVALENT	1
SENTIENT MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
SHANGHAI OMNI LASER SKINOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., 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
SILHOUET-TONE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SMEDTRUM MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SNJ CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SNJ CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLITON INC.
	SUBSTANTIALLY EQUIVALENT	5
SOLTA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SQUALUS MED LTD.
	SUBSTANTIALLY EQUIVALENT	1
STEP UP SKIN LASER, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRATA SKIN SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
SYNERON-CANDELA
	SUBSTANTIALLY EQUIVALENT	1
SYNERON-CANDELA CORP
	SUBSTANTIALLY EQUIVALENT	1
TERMOSALUD
	SUBSTANTIALLY EQUIVALENT	1
VENUS CONCEPT USA INC.
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	4
W & R INVESTMENTS, LLC DBA LASER ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
WEIFANG KM 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	6
WONTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN DIMED LASER TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN PIOON TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.
	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	1
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
2018	3525	3525
2019	2709	2709
2020	2182	2182
2021	3467	3467
2022	2290	2754
2023	781	781

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3282	3282
Adverse Event Without Identified Device or Use Problem	2049	2049
Fracture	1656	1656
Decrease in Suction	1261	1725
Appropriate Term/Code Not Available	920	920
Temperature Problem	750	750
Detachment of Device or Device Component	667	667
Defective Device	482	482
Therapeutic or Diagnostic Output Failure	449	449
Output Problem	355	355
Firing Problem	351	351
Overheating of Device	311	311
Device Displays Incorrect Message	263	263
Device Operational Issue	233	233
Degraded	223	223
Mechanical Problem	216	216
Suction Problem	208	208
Failure to Align	189	189
Insufficient Information	186	186
Failure to Fire	154	154
Use of Device Problem	151	151
Computer Software Problem	151	151
Device Operates Differently Than Expected	140	140
Connection Problem	135	135
Misfire	127	127
Unexpected Therapeutic Results	124	124
Power Problem	121	121
Failure to Deliver Energy	116	116
No Apparent Adverse Event	105	105
Suction Failure	99	99
Crack	94	94
Failure to Cut	94	94
Material Integrity Problem	92	92
Fire	91	91
Electrical /Electronic Property Problem	90	90
Optical Problem	87	87
Thermal Decomposition of Device	83	83
Incorrect, Inadequate or Imprecise Result or Readings	80	80
Energy Output Problem	79	79
Loss of or Failure to Bond	74	74
Smoking	70	70
Melted	66	66
Gas Output Problem	66	66
Device Contaminated During Manufacture or Shipping	65	65
Contamination	62	62
Insufficient Heating	58	58
Improper or Incorrect Procedure or Method	57	57
Material Deformation	56	56
Material Fragmentation	55	55
Material Separation	54	54
Defective Component	53	53
Output below Specifications	51	51
No Device Output	48	48
Detachment Of Device Component	46	46
Infusion or Flow Problem	45	45
Failure to Power Up	42	42
Unexpected Shutdown	41	41
Noise, Audible	40	40
Physical Resistance/Sticking	39	39
Unexpected/Unintended Radiation Output	39	39
Protective Measures Problem	38	38
Communication or Transmission Problem	38	38
Patient-Device Incompatibility	35	35
Inflation Problem	35	35
Inadequacy of Device Shape and/or Size	34	34
Fluid/Blood Leak	29	29
Display or Visual Feedback Problem	29	29
Gas/Air Leak	27	27
Loose or Intermittent Connection	26	26
Device Damaged Prior to Use	26	26
Sparking	26	26
Device Inoperable	24	24
Device Emits Odor	22	22
Use of Incorrect Control/Treatment Settings	22	22
Calibration Problem	21	21
Material Twisted/Bent	21	21
Peeled/Delaminated	20	20
No Display/Image	19	19
Failure of Device to Self-Test	17	17
Material Split, Cut or Torn	16	16
Leak/Splash	16	16
Material Puncture/Hole	16	16
Tear, Rip or Hole in Device Packaging	15	15
Failure to Read Input Signal	15	15
Excessive Heating	14	14
Component Missing	13	13
Loss of Power	13	13
Unintended Application Program Shut Down	12	12
Human-Device Interface Problem	12	12
Radiation Underexposure	11	11
Activation Problem	11	11
Wireless Communication Problem	11	11
Device Handling Problem	11	11
Complete Loss of Power	10	10
Unsealed Device Packaging	10	10
Delivered as Unsterile Product	9	9
Material Discolored	9	9
Disconnection	9	9
Charred	9	9
Circuit Failure	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4995	5293
No Consequences Or Impact To Patient	3551	3551
No Known Impact Or Consequence To Patient	3030	3030
Insufficient Information	504	504
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	436	602
Burn(s)	421	421
Keratitis	368	368
No Code Available	196	197
Visual Impairment	192	192
Blurred Vision	149	149
Pain	125	126
No Patient Involvement	122	122
Visual Disturbances	86	86
Eye Injury	83	83
Tissue Damage	82	82
Radiation Exposure, Unintended	70	70
Hemorrhage/Bleeding	69	69
Foreign Body In Patient	63	63
Patient Problem/Medical Problem	51	51
Partial thickness (Second Degree) Burn	51	51
Scar Tissue	50	50
Device Embedded In Tissue or Plaque	49	49
Superficial (First Degree) Burn	46	46
Urinary Retention	40	40
Headache	40	40
Urinary Tract Infection	39	39
Inflammation	39	39
Stenosis	39	39
No Information	36	36
Eye Pain	36	36
Muscle Weakness	36	36
Hematuria	35	35
Corneal Abrasion	33	33
Skin Discoloration	31	31
Discomfort	31	31
Foreign Body Sensation in Eye	30	30
Dry Eye(s)	28	28
Memory Loss/Impairment	27	27
Unspecified Infection	26	26
Swelling	26	26
Intracranial Hemorrhage	26	26
Erythema	25	25
Burning Sensation	25	25
Burn, Thermal	25	25
Unspecified Tissue Injury	25	25
Blister	24	24
Red Eye(s)	24	24
Swelling/ Edema	23	23
Unspecified Kidney or Urinary Problem	23	23
Halo	22	22
Perforation	22	22
Scarring	21	21
Seizures	21	21
Dysphasia	21	21
Eye Infections	21	21
Dysuria	20	20
Paresis	20	20
Edema	20	20
Hematoma	20	20
Fever	20	20
Incontinence	19	19
Nerve Damage	19	19
Neurological Deficit/Dysfunction	18	18
Full thickness (Third Degree) Burn	17	17
Blood Loss	16	16
Corneal Clouding/Hazing	15	15
Cognitive Changes	14	14
Complaint, Ill-Defined	14	14
Injury	14	14
Convulsion/Seizure	14	14
Hypersensitivity/Allergic reaction	13	13
Thrombus	13	13
Cerebral Edema	12	12
Urinary Frequency	12	12
Loss of Vision	12	12
Ambulation Difficulties	12	12
Weakness	11	11
Nausea	11	11
Irritation	11	11
Corneal Perforation	11	11
Bacterial Infection	10	10
Therapeutic Effects, Unexpected	10	10
Unspecified Nervous System Problem	10	10
Skin Inflammation/ Irritation	10	10
Depression	9	9
Numbness	9	9
Bruise/Contusion	9	9
Death	9	9
Corneal Edema	8	8
Sepsis	8	8
Post Operative Wound Infection	8	8
Hydrocephalus	8	8
Iatrogenic Source	7	7
Impaired Healing	7	7
Vomiting	7	7
Anxiety	7	7
Corneal Infiltrates	7	7
Thrombosis	7	7
Increased Sensitivity	7	7
Fistula	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Aerolase Corporation	II	Jan-03-2020
2	Angiodynamics, Inc.	II	Sep-27-2022
3	Angiodynamics, Inc.	II	Aug-30-2019
4	Beijing Syntech Laser Co., Ltd	II	May-02-2018
5	Boston Scientific Corporation	III	Jul-15-2022
6	Boston Scientific Corporation	II	Apr-24-2020
7	Boston Scientific Corporation	II	May-22-2019
8	Boston Scientific Corporation	II	Mar-05-2018
9	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
10	Candela Corporation	II	Oct-24-2019
11	Clarus Medical, Llc	II	Sep-03-2021
12	Dornier Medtech America, Inc.	II	May-21-2019
13	Inova Lasers LLC	II	Nov-17-2020
14	Iridex Corporation	II	Mar-16-2018
15	Leoni Fiber Optics GmbH	II	Dec-07-2018
16	Medtronic Navigation, Inc.	II	May-06-2020
17	Medtronic Navigation, Inc.	II	Jul-19-2018
18	Medtronic Sofamor Danek USA Inc	II	Jul-23-2020
19	Monteris Medical Corp	I	Mar-20-2018
20	Olympus Corporation of the Americas	II	Jun-28-2022
21	Olympus Corporation of the Americas	II	Aug-15-2021
22	Quanta System, S.p.A.	II	Jun-10-2021
23	Ra Medical Systems, Inc.	II	Apr-01-2020
24	Xintec Corp	III	Oct-18-2019