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
ACTIVE OPTICAL SYSTEMS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	1
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALMA LASERS INC.
	SUBSTANTIALLY EQUIVALENT	2
ALMA LASERS LTD
	SUBSTANTIALLY EQUIVALENT	1
ALMA LASERS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ALMA LTD
	SUBSTANTIALLY EQUIVALENT	1
AMA NETWORK INC
	SUBSTANTIALLY EQUIVALENT	1
AMBICARE HEALTH LTD
	SUBSTANTIALLY EQUIVALENT	1
AMI INC.
	SUBSTANTIALLY EQUIVALENT	2
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ASCLEPION LASER TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	2
AVENDA HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
AZENA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BEIJING ADSS DEVELOPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	3
BEIJING HUACHENG TAIKE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING LEAD BEAUTY S & T CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
BEIJING SANO LASER S&T DEVELOPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING SUPERLASER TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
BIO-MED USA INC
	SUBSTANTIALLY EQUIVALENT	2
BIO-MED USA INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOLASE, INC
	SUBSTANTIALLY EQUIVALENT	3
BIOLASE, INC.
	SUBSTANTIALLY EQUIVALENT	3
BIOS S.R.L
	SUBSTANTIALLY EQUIVALENT	1
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
BISON MEDICAL CO LTD
	SUBSTANTIALLY EQUIVALENT	1
BISON MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BLUECORE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
C.I.S LTD
	SUBSTANTIALLY EQUIVALENT	1
CANADIAN PIONEER MEDICAL TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CANDELA CORP.
	SUBSTANTIALLY EQUIVALENT	1
CANDELA CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CAO GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	5
CERAMOPTEC GMBH
	SUBSTANTIALLY EQUIVALENT	1
CLINICAL LASERTHERMIA SYSTEMS AB
	SUBSTANTIALLY EQUIVALENT	2
CLINICAL LASERTHERMIA SYSTEMS, AB
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
CUTERA, INC.
	SUBSTANTIALLY EQUIVALENT	5
CYDEN LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CYNOSURE LLC
	SUBSTANTIALLY EQUIVALENT	2
CYNOSURE, INC
	SUBSTANTIALLY EQUIVALENT	2
DAEJU MEDITECH ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	2
DIOTECH CO
	SUBSTANTIALLY EQUIVALENT	1
DOMINION AESTHETIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH 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	4
EL.EN. ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	3
ELEMENIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELEN ELECTRONIC ENGINEERING SPA
	SUBSTANTIALLY EQUIVALENT	1
ELLIPSE A/S
	SUBSTANTIALLY EQUIVALENT	3
EPILADY 2000 LLC
	SUBSTANTIALLY EQUIVALENT	1
FINEMEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOCUS MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
FOCUS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
FORMATK SYSTEMS LTD.
	SUBSTANTIALLY EQUIVALENT	3
FOTONA D.O.O.
	SUBSTANTIALLY EQUIVALENT	9
GLOBAL MED SYSTEMS SL
	SUBSTANTIALLY EQUIVALENT	1
GME GERMAN MEDICAL ENGINEERING GMBH
	SUBSTANTIALLY EQUIVALENT	3
GUANGZHOU HUAFEI TONGDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	1
HIGH TECHNOLOGY PRODUCTS SLU
	SUBSTANTIALLY EQUIVALENT	3
HIRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HULASER, INC.
	SUBSTANTIALLY EQUIVALENT	1
HYPER PHOTONICS SRL
	SUBSTANTIALLY EQUIVALENT	1
I.T.S. GROUP S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
IDS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO LTD
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INMODE MD LTD.
	SUBSTANTIALLY EQUIVALENT	3
INNOVAQUARTZ LLC
	SUBSTANTIALLY EQUIVALENT	2
INTELLIGENT SENSORY CONCEPT SA
	SUBSTANTIALLY EQUIVALENT	1
IRIDEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
JEISYS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
LAMEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LASER PERIPHERALS, LLC
	SUBSTANTIALLY EQUIVALENT	1
LASEROPTEK CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
LASEROPTEK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
LASEROPTEK CO.LTD
	SUBSTANTIALLY EQUIVALENT	1
LAZON MEDICAL LASER CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LEONI FIBER OPTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIGHTMED DENTALTECHNOLOGY CORP.
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSCALPEL LLC
	SUBSTANTIALLY EQUIVALENT	1
LITECURE, LLC
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS LTD
	SUBSTANTIALLY EQUIVALENT	1
LUMENIS LTD.
	SUBSTANTIALLY EQUIVALENT	7
LUMENIS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
LUTRONIC GLOBAL
	SUBSTANTIALLY EQUIVALENT	1
LUVO MEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	2
M&T S.R.L
	SUBSTANTIALLY EQUIVALENT	1
M&T SRL
	SUBSTANTIALLY EQUIVALENT	2
MEDICO USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDKEY, LLC
	SUBSTANTIALLY EQUIVALENT	1
MERIDIAN AG
	SUBSTANTIALLY EQUIVALENT	1
MILLENNIUM DENTAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
MONTERIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
MONTERIS MEDICAL,
	SUBSTANTIALLY EQUIVALENT	1
MONTERIS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
NOVIAN HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
OD-OS GMBH
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	1
OMNIGUIDE, INC
	SUBSTANTIALLY EQUIVALENT	1
OMNIGUIDE, INC.
	SUBSTANTIALLY EQUIVALENT	2
PATIENT POCKET LLC
	SUBSTANTIALLY EQUIVALENT	1
PRECISE LIGHT SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
QUANTA SYSTEM S.P.A.
	SUBSTANTIALLY EQUIVALENT	5
QUANTA SYSTEM SPA
	SUBSTANTIALLY EQUIVALENT	19
QUANTA SYSTEM, S.P.A
	SUBSTANTIALLY EQUIVALENT	1
QUANTA SYSTEM, S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
QUANTEL MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
RAJA TRADING COMPANY, INC.
	SUBSTANTIALLY EQUIVALENT	1
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
SCITON, INC
	SUBSTANTIALLY EQUIVALENT	2
SCITON, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HUAMEI TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGDONG HUAMEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. 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	1
SILHOUET-TONE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SOLITON INC.
	SUBSTANTIALLY EQUIVALENT	4
STEP UP SKIN LASER, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRATA SKIN SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
SURGICAL LASER INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
SYNERON CANDELA CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
SYNERON-CANDELA
	SUBSTANTIALLY EQUIVALENT	1
SYNERON-CANDELA CORP
	SUBSTANTIALLY EQUIVALENT	1
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS)
	SUBSTANTIALLY EQUIVALENT	1
U.S. LASER WORX
	SUBSTANTIALLY EQUIVALENT	1
UVBIOTEK, LLC
	SUBSTANTIALLY EQUIVALENT	1
VENUS CONCEPT LTD.
	SUBSTANTIALLY EQUIVALENT	1
VENUS CONCEPT USA INC.
	SUBSTANTIALLY EQUIVALENT	1
VIAX DENTAL LAB
	SUBSTANTIALLY EQUIVALENT	1
VIORA LTD.
	SUBSTANTIALLY EQUIVALENT	2
VITAGE LED LTD
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE
	SUBSTANTIALLY EQUIVALENT	1
VYDENCE MEDICAL INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	2
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	5
WONTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
YERIM ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHENGZHOU BESTVIEW ST CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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
ZOLAR TECHNOLOGY & MFG CO. INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2016	2582	2591
2017	2974	2974
2018	3523	3523
2019	2709	2709
2020	2182	2182
2021	2667	2667

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	3378	3385
Break	3055	3055
Temperature Problem	2531	2531
Adverse Event Without Identified Device or Use Problem	2059	2059
Appropriate Term/Code Not Available	1481	1481
Detachment of Device or Device Component	921	921
Decrease in Suction	887	887
Device Operates Differently Than Expected	667	667
Insufficient Information	442	442
Therapeutic or Diagnostic Output Failure	415	415
Suction Problem	331	331
Device Displays Incorrect Message	300	300
Overheating of Device	281	281
Device Operational Issue	237	237
Device Inoperable	211	211
Defective Device	204	204
Unexpected Therapeutic Results	199	199
Detachment Of Device Component	197	199
Output Problem	187	187
Crack	183	183
Mechanical Problem	180	180
Degraded	169	169
Misfire	160	160
Computer Software Problem	156	156
Use of Device Problem	156	156
Failure to Fire	126	126
Failure to Cut	115	115
Material Deformation	107	107
Thermal Decomposition of Device	103	103
Failure to Deliver Energy	102	102
Material Integrity Problem	96	96
Suction Failure	94	94
No Apparent Adverse Event	88	88
Firing Problem	83	83
Connection Problem	82	82
Failure to Align	75	75
Material Fragmentation	74	74
Optical Problem	71	71
Improper or Incorrect Procedure or Method	71	71
Device Damaged Prior to Use	68	68
Electrical /Electronic Property Problem	68	68
Melted	67	67
Material Separation	59	59
Power Problem	58	58
Device Contaminated During Manufacture or Shipping	58	58
Incorrect, Inadequate or Imprecise Resultor Readings	55	55
Energy Output Problem	51	51
Inflation Problem	50	50
Insufficient Heating	49	49
No Device Output	45	45
Smoking	44	44
No Display/Image	40	40
Device Or Device Fragments Location Unknown	40	40
Failure to Power Up	39	39
Defective Component	39	39
Inadequacy of Device Shape and/or Size	36	36
Charred	36	36
Protective Measures Problem	36	36
Infusion or Flow Problem	36	36
Gas Leak	35	35
Patient-Device Incompatibility	34	34
Material Perforation	34	34
Noise, Audible	33	33
Leak/Splash	33	33
Output below Specifications	31	31
Unexpected/Unintended Radiation Output	31	31
Display or Visual Feedback Problem	31	31
Calibration Problem	29	29
Fire	28	28
Gas Output Problem	27	27
Loss of Power	26	26
Loss of or Failure to Bond	23	23
Unexpected Shutdown	23	23
Physical Resistance/Sticking	22	22
Loose or Intermittent Connection	20	20
Bent	20	20
Device Emits Odor	20	20
Peeled/Delaminated	19	19
Pressure Problem	17	17
Device Issue	16	16
Device Handling Problem	16	16
Sparking	15	15
Device Dislodged or Dislocated	15	15
Material Twisted/Bent	15	15
Air Leak	15	15
Use of Incorrect Control Settings	15	15
Positioning Problem	15	15
Failure of Device to Self-Test	15	15
Tear, Rip or Hole in Device Packaging	14	14
Device Stops Intermittently	14	14
Fluid Leak	14	14
Flare or Flash	13	13
Material Puncture/Hole	12	12
Difficult to Remove	12	12
Unsealed Device Packaging	12	12
Hole In Material	11	11
Burst Container or Vessel	11	11
Human Factors Issue	11	11
Activation Problem	11	11
Human-Device Interface Problem	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	5719	5728
No Consequences Or Impact To Patient	5096	5096
No Clinical Signs, Symptoms or Conditions	2104	2104
Burn(s)	485	485
Keratitis	485	485
No Code Available	378	379
Insufficient Information	275	275
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	259	259
Visual Impairment	257	257
No Patient Involvement	180	180
Blurred Vision	175	175
Pain	142	143
No Information	140	140
Patient Problem/Medical Problem	109	109
Tissue Damage	106	106
Visual Disturbances	105	105
Eye Injury	92	92
Device Embedded In Tissue or Plaque	82	82
Radiation Exposure, Unintended	78	78
Iatrogenic Source	78	78
Hemorrhage/Bleeding	72	72
Partial thickness (Second Degree) Burn	69	69
Corneal Clouding/Hazing	60	60
Superficial (First Degree) Burn	59	59
Neurological Deficit/Dysfunction	59	59
Headache	57	57
Edema	57	57
Foreign Body In Patient	55	55
Seizures	49	49
Burn, Thermal	45	45
Memory Loss/Impairment	45	45
Scarring	42	42
Complaint, Ill-Defined	41	41
Inflammation	40	40
Swelling	39	39
Cognitive Changes	39	39
Burning Sensation	38	38
Weakness	36	36
Urinary Tract Infection	36	36
Injury	35	35
Discomfort	35	35
Skin Discoloration	35	35
Muscle Weakness	34	34
Corneal Abrasion	33	33
Urinary Retention	33	33
Death	33	33
Scar Tissue	32	32
Foreign Body Sensation in Eye	30	30
Dry Eye(s)	30	30
Halo	29	29
Intracranial Hemorrhage	28	28
Paresis	27	27
Unspecified Infection	27	27
Hematuria	26	26
Nerve Damage	23	23
Eye Pain	23	23
Incontinence	22	22
Corneal Edema	22	22
Eye Infections	21	21
Full thickness (Third Degree) Burn	21	21
Stenosis	21	21
Red Eye(s)	20	20
Loss of Vision	20	20
Erythema	19	19
Perforation	19	19
Irritation	18	18
Thrombosis	18	18
Blood Loss	18	18
Thrombus	17	17
Hematoma	17	17
Dysuria	15	15
Hydrocephalus	14	14
Reaction	12	12
Therapeutic Effects, Unexpected	12	12
Increased Sensitivity	12	12
Corneal Perforation	12	12
Fever	11	11
Dysphasia	11	11
Nausea	11	11
Bruise/Contusion	10	10
Therapeutic Response, Decreased	10	10
Corneal Infiltrates	10	10
Unspecified Tissue Injury	10	10
Swelling/ Edema	10	10
Skin Irritation	10	10
Numbness	10	10
Urinary Frequency	9	9
Convulsion/Seizure	9	9
Hypersensitivity/Allergic reaction	9	9
Itching Sensation	9	9
Vomiting	9	9
Brain Injury	8	8
Impaired Healing	7	7
Post Operative Wound Infection	7	7
Bacterial Infection	7	7
Abscess	7	7
Pulmonary Embolism	6	6
Abrasion	6	6
Radiation Burn	6	6
Emotional Changes	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Aerolase Corporation	II	Jan-03-2020
2	Angiodynamics, Inc.	II	Aug-30-2019
3	Beijing Syntech Laser Co., Ltd	II	May-02-2018
4	Boston Scientific Corporation	II	Apr-24-2020
5	Boston Scientific Corporation	II	May-22-2019
6	Boston Scientific Corporation	II	Mar-05-2018
7	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
8	Candela Corporation	II	Oct-24-2019
9	Clarus Medical, Llc	II	Sep-03-2021
10	Cook Inc.	II	Jun-14-2017
11	Cook Inc.	II	Jun-05-2017
12	Dornier Medtech America, Inc.	II	May-21-2019
13	Ellipse A/S	II	Jun-09-2016
14	Inova Lasers LLC	II	Nov-17-2020
15	Iridex Corporation	II	Mar-16-2018
16	Laserex Systems Inc.	II	Jun-06-2017
17	Leoni Fiber Optics GmbH	II	Dec-07-2018
18	Lumenis Limited	II	Oct-23-2016
19	Lumenis Ltd	II	May-13-2016
20	Medtronic Navigation, Inc.	II	May-06-2020
21	Medtronic Navigation, Inc.	II	Jul-19-2018
22	Medtronic Navigation, Inc.	II	Oct-18-2017
23	Medtronic Navigation, Inc.	II	Jul-03-2017
24	Medtronic Navigation, Inc.	II	May-16-2016
25	Medtronic Sofamor Danek USA Inc	II	Jul-23-2020
26	Monteris Medical Corp	I	Mar-20-2018
27	Monteris Medical Corp	I	May-16-2016
28	New Star Lasers, Inc.	II	Sep-30-2016
29	Olympus Corporation of the Americas	II	Aug-15-2021
30	Quanta System, S.p.A.	II	Jun-10-2021
31	Ra Medical Systems, Inc.	II	Apr-01-2020
32	Strata Skin Sciences, Inc.	II	Mar-27-2017
33	Xintec Corp	III	Oct-18-2019
34	Xintec Corp	II	Aug-02-2017