FDA.reportPublic FDA data

510(k) K241916

Device
TearRepair Liquid Skin Protectant
Applicant
Optmed, Inc.
510(k) number
K241916
Product code
KMF
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-27
Date received
2024-07-01
Regulation
880.5090
Classification name
Bandage, Liquid
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nitasha Yajnik
Address
745 Fifth Ave. Suite 500 New York NY US 10151 10151

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KMF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182733Rochal Bioshield Silicone FilmRochal Industries, LLC2019-06-27
K171148Aleo BME Liquid BandageAleo Bme, Inc.2018-01-12
K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare2016-08-23
K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC2016-07-26
K131384KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGEKericure, Inc.2014-08-07
K133443MARATHON NO STING LIQUID SKIN PROTECTANTAdvanced Medical Solutions (Plymouth), Ltd.2014-07-10
K120059LIQUID BANDAGEChesson Laboratory Associates, Inc.2012-05-17
K092712SKIN BARRIER FILMLodestar Products, Inc.2010-02-23
K083087ECOCELPolichem S.A2009-08-07
K083913CHESSON LABS LIQUID BANDAGEChesson Laboratory Associates, Inc.2009-07-31
K083752GLUSEAL 90, MODEL GLU9010Glustitch, Inc.2009-02-23
K082703MRDH BANDAGEMarine Polymer Technologies, Inc.2008-10-14
K081009NEUTROPHASENovabay Pharmaceuticals2008-05-20
K073663GELSPRAY WOUND DRESSINGBiocure, Inc.2008-01-30
K063202PRODERMA LIQUID BANDAGEProcurement Technology Systems, LLC2007-05-02