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Miscellaneous
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
3
Product Code
QQU
Digital Therapy Device For Amblyopia
2
Product Code
HPX
Lens, Contact (Polymethylmethacrylate)
U
Product Code
LOG
Catheter, Balloon For Retinal Reattachment
3
Product Code
LOH
System, Identification, Contact Lens
3
Product Code
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
3
Product Code
LQB
Medical Computers And Software For Ophthalmic Use
3
Product Code
LQE
Implant, Corneal, Refractive
3
Product Code
LXQ
Cup, Eye
U
Product Code
LYX
Media, Corneal Storage
U
Product Code
LZQ
Tissue Adhesive For Ophthalmic Use
3
Product Code
LZR
Ultrasound, Cyclodestructive
3
Product Code
LZS
Excimer Laser System
3
Product Code
LZU
Plug, Punctum
U
Product Code
K
24
1229
Hello,eyes® BIO Plug
U
Cleared 510(K)
K
22
2164
Visant Medical Canalicular Plug
U
Cleared 510(K)
K
21
3988
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
U
Cleared 510(K)
K
19
0210
Tear Pool Dissolvable Punctum Plugs
U
Cleared 510(K)
K
16
2361
Soft Plug Extended Duration 180 Canalicular Plug
U
Cleared 510(K)
K
16
1673
LacriPro Punctum Plug
U
Cleared 510(K)
K
15
0288
PDO Absorbable Punctum Plug
U
Cleared 510(K)
K
14
0352
VERAPLUG
U
Cleared 510(K)
K
14
0711
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
U
Cleared 510(K)
K
14
0026
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
U
Cleared 510(K)
K
09
0938
FLOW CONTROLLER
U
Cleared 510(K)
K
06
1398
SNUG PLUG PUNCTUM PLUG
U
Cleared 510(K)
K
05
3333
EAGLEVISION GELLANSERTS, MODEL REF 0040
U
Cleared 510(K)
K
05
0851
DELTA PUNCTUM PLUG
U
Cleared 510(K)
K
04
0912
HYDROGEL CANALICULAR PLUG
U
Cleared 510(K)
K
04
0231
INTELIPORT OCCLUDING DEVICE
U
Cleared 510(K)
K
03
0300
OPAQUE HERRICK LACRIMAL PLUG
U
Cleared 510(K)
K
02
2043
SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503
U
Cleared 510(K)
K
02
1936
MOIST PUNCTAL PLUG SYSTEM
U
Cleared 510(K)
K
02
0882
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
U
Cleared 510(K)
K
02
1831
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
U
Cleared 510(K)
K
01
3613
SOFT PLUG ABSORBABLE PLUG-SA
U
Cleared 510(K)
K
00
1768
OCCU-FLO PUNCTUM PLUGS
U
Cleared 510(K)
K
00
1234
BIOINSULATED SILICONE PUNCTUM PLUG
U
Cleared 510(K)
K
00
1737
OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM
U
Cleared 510(K)
K
99
1130
FLEXPLUG
U
Cleared 510(K)
K
98
0844
SURGIDEV SILICONE PUNCTUM PLUG
U
Cleared 510(K)
K
98
0437
SILICONE PUNCTAL PLUG
U
Cleared 510(K)
K
97
2523
PUNCTUAL OCCLUDER
U
Cleared 510(K)
K
97
0631
PUNCTUAL OCCLUDER
U
Cleared 510(K)
K
96
3708
HERRICK ULTIMATE PUNCTUM PLUG
U
Cleared 510(K)
K
96
3501
HERRICK ULTIMATE PUNCTUM PLUG
U
Cleared 510(K)
K
96
4774
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
U
Cleared 510(K)
K
96
1909
READY-SET PUNCTAL PLUGS
U
Cleared 510(K)
K
95
3394
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
U
Cleared 510(K)
K
95
4094
OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
U
Cleared 510(K)
K
95
0569
OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
U
Cleared 510(K)
K
94
6357
COLLAGEN INTRACANALICULAR PLUG
U
Cleared 510(K)
K
94
5906
SILICONE PUNCTAL PLUG
U
Cleared 510(K)
K
91
5809
VISITEC CANALICULAR STENT
U
Cleared 510(K)
K
90
5427
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
U
Cleared 510(K)
K
91
1108
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
U
Cleared 510(K)
K
90
5750
LACRIMAL PLUG
U
Cleared 510(K)
K
89
7190
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
U
Cleared 510(K)
K
89
6175
HERRICK LACRIMAL PLUG TM.
U
Cleared 510(K)
K
89
5342
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
U
Cleared 510(K)
K
89
0714
LACRIMAL EFFICIENCY TEST (TM)
U
Cleared 510(K)
K
89
0919
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
U
Cleared 510(K)
K
89
0920
EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
U
Cleared 510(K)
MRJ
Ring, Endocapsular
3
Product Code
MSI
Solution, Cleaning / Lubricating, Artificial Eye
3
Product Code
MTA
Lens, Intraocular, Phakic
3
Product Code
MUR
Graft, Sclera, Reinforcement
3
Product Code
MWD
Electrosurgical, Radio Frequency, Refractive Correction
3
Product Code
NBF
Prosthesis, Retinal
F
Product Code
NCJ
Telescope, Implantable, Miniature
3
Product Code
ODK
Refractive Corneal Implant
F
Product Code
OKS
Lacrimal Stents And Intubation Sets
U
Product Code
OTL
Femtosecond Laser System For Refractive Correction
3
Product Code
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
N
Product Code
PFZ
Ophthalmic Sealant
3
Product Code
QBT
Artificial Iris
3
Product Code
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
3
Product Code
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
2
Product Code
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
2
Product Code
QQJ
Applicator, Negative Pressure, External, Ocular
2
Product Code
SDE
Light Based Device For Dry Age-Related Macular Degeneration
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
OP
/
OP-misc
/
LZU
/
K021936
View Source
MOIST PUNCTAL PLUG SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K021936
510(k) Type
Traditional
Applicant
MOIST MEDICAL INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/2002
Days to Decision
126 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
QQU
Digital Therapy Device For Amblyopia
HPX
Lens, Contact (Polymethylmethacrylate)
LOG
Catheter, Balloon For Retinal Reattachment
LOH
System, Identification, Contact Lens
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
LQB
Medical Computers And Software For Ophthalmic Use
LQE
Implant, Corneal, Refractive
LXQ
Cup, Eye
LYX
Media, Corneal Storage
LZQ
Tissue Adhesive For Ophthalmic Use
LZR
Ultrasound, Cyclodestructive
LZS
Excimer Laser System
LZU
Plug, Punctum
K
24
1229
Hello,eyes® BIO Plug
K
22
2164
Visant Medical Canalicular Plug
K
21
3988
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
K
19
0210
Tear Pool Dissolvable Punctum Plugs
K
16
2361
Soft Plug Extended Duration 180 Canalicular Plug
K
16
1673
LacriPro Punctum Plug
K
15
0288
PDO Absorbable Punctum Plug
K
14
0352
VERAPLUG
K
14
0711
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
K
14
0026
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
K
09
0938
FLOW CONTROLLER
K
06
1398
SNUG PLUG PUNCTUM PLUG
K
05
3333
EAGLEVISION GELLANSERTS, MODEL REF 0040
K
05
0851
DELTA PUNCTUM PLUG
K
04
0912
HYDROGEL CANALICULAR PLUG
K
04
0231
INTELIPORT OCCLUDING DEVICE
K
03
0300
OPAQUE HERRICK LACRIMAL PLUG
K
02
2043
SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503
K
02
1936
MOIST PUNCTAL PLUG SYSTEM
K
02
0882
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
K
02
1831
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
K
01
3613
SOFT PLUG ABSORBABLE PLUG-SA
K
00
1768
OCCU-FLO PUNCTUM PLUGS
K
00
1234
BIOINSULATED SILICONE PUNCTUM PLUG
K
00
1737
OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM
K
99
1130
FLEXPLUG
K
98
0844
SURGIDEV SILICONE PUNCTUM PLUG
K
98
0437
SILICONE PUNCTAL PLUG
K
97
2523
PUNCTUAL OCCLUDER
K
97
0631
PUNCTUAL OCCLUDER
K
96
3708
HERRICK ULTIMATE PUNCTUM PLUG
K
96
3501
HERRICK ULTIMATE PUNCTUM PLUG
K
96
4774
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
K
96
1909
READY-SET PUNCTAL PLUGS
K
95
3394
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
K
95
4094
OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
K
95
0569
OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
K
94
6357
COLLAGEN INTRACANALICULAR PLUG
K
94
5906
SILICONE PUNCTAL PLUG
K
91
5809
VISITEC CANALICULAR STENT
K
90
5427
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
K
91
1108
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
K
90
5750
LACRIMAL PLUG
K
89
7190
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K
89
6175
HERRICK LACRIMAL PLUG TM.
K
89
5342
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
K
89
0714
LACRIMAL EFFICIENCY TEST (TM)
K
89
0919
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K
89
0920
EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
MRJ
Ring, Endocapsular
MSI
Solution, Cleaning / Lubricating, Artificial Eye
MTA
Lens, Intraocular, Phakic
MUR
Graft, Sclera, Reinforcement
MWD
Electrosurgical, Radio Frequency, Refractive Correction
NBF
Prosthesis, Retinal
NCJ
Telescope, Implantable, Miniature
ODK
Refractive Corneal Implant
OKS
Lacrimal Stents And Intubation Sets
OTL
Femtosecond Laser System For Refractive Correction
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
PFZ
Ophthalmic Sealant
QBT
Artificial Iris
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
QQJ
Applicator, Negative Pressure, External, Ocular
SDE
Light Based Device For Dry Age-Related Macular Degeneration
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
OP-misc
/
LZU
/
K021936
View Source
MOIST PUNCTAL PLUG SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K021936
510(k) Type
Traditional
Applicant
MOIST MEDICAL INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/2002
Days to Decision
126 days
Submission Type
Summary