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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
FPX
Strip, Adhesive, Closure, Skin
1
Product Code
FPY
Sheet, Burn
1
Product Code
KGX
Tape And Bandage, Adhesive
1
Product Code
KMF
Bandage, Liquid
1
Product Code
K
24
1916
TearRepair Liquid Skin Protectant
1
Cleared 510(K)
K
18
2733
Rochal Bioshield Silicone Film
1
Cleared 510(K)
K
17
1148
Aleo BME Liquid Bandage
1
Cleared 510(K)
K
15
3571
Cavilon Advanced High Endurance Skin Protectant
1
Cleared 510(K)
K
16
0684
Atteris No-Sting Skin Protectant
1
Cleared 510(K)
K
13
1384
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
1
Cleared 510(K)
K
13
3443
MARATHON NO STING LIQUID SKIN PROTECTANT
1
Cleared 510(K)
K
12
0059
LIQUID BANDAGE
1
Cleared 510(K)
K
09
2712
SKIN BARRIER FILM
1
Cleared 510(K)
K
08
3087
ECOCEL
1
Cleared 510(K)
Show All 223 Submissions
LRS
I.V. Start Kit
2
Product Code
MCY
Wound Dressing Kit
2
Product Code
MHW
Dressing, Compression
1
Product Code
NEC
Bandage, Liquid, Skin Protectant
1
Product Code
OXQ
Dressing Change Tray
1
Product Code
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
1
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
KMF
/
K241916
View Source
TearRepair Liquid Skin Protectant
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241916
510(k) Type
Traditional
Applicant
OptMed, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2024
Days to Decision
88 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
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
FPX
Strip, Adhesive, Closure, Skin
FPY
Sheet, Burn
KGX
Tape And Bandage, Adhesive
KMF
Bandage, Liquid
K
24
1916
TearRepair Liquid Skin Protectant
K
18
2733
Rochal Bioshield Silicone Film
K
17
1148
Aleo BME Liquid Bandage
K
15
3571
Cavilon Advanced High Endurance Skin Protectant
K
16
0684
Atteris No-Sting Skin Protectant
K
13
1384
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
K
13
3443
MARATHON NO STING LIQUID SKIN PROTECTANT
K
12
0059
LIQUID BANDAGE
K
09
2712
SKIN BARRIER FILM
K
08
3087
ECOCEL
Show All 223 Submissions
LRS
I.V. Start Kit
MCY
Wound Dressing Kit
MHW
Dressing, Compression
NEC
Bandage, Liquid, Skin Protectant
OXQ
Dressing Change Tray
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
KMF
/
K241916
View Source
TearRepair Liquid Skin Protectant
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241916
510(k) Type
Traditional
Applicant
OptMed, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2024
Days to Decision
88 days
Submission Type
Summary