TearRepair Liquid Skin Protectant

FDA 510(k) K241916 · Optmed, Inc.

Substantially Equivalent

510(k) numberK241916

Submission

Device name
TearRepair Liquid Skin Protectant
Applicant
Optmed, Inc.
New York, NY, US
Received
July 1, 2024
Decision date
September 27, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KMF – Bandage, Liquid
Device class
Class I (low risk)
Regulation
21 CFR 880.5090
Specialty
General Hospital

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K182733Rochal Bioshield Silicone FilmKMF · Traditional Rochal Industries, LLC06/27/2019SE
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K153571Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional 3M Healthcare08/23/2016SE
K160684Atteris No-Sting Skin ProtectantKMF · Traditional Rochal Industries, LLC07/26/2016SE
K131384Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional Kericure, Inc.08/07/2014SE
K133443Marathon No Sting Liquid Skin ProtectantKMF · Traditional Advanced Medical Solutions (Plymouth), Ltd.07/10/2014SE
K120059Liquid BandageKMF · Traditional Chesson Laboratory Associates, Inc.05/17/2012SE
K092712Skin Barrier FilmKMF · Traditional Lodestar Products, Inc.02/23/2010SE
K083087EcocelKMF · Traditional Polichem S.A08/07/2009SE
K083913Chesson Labs Liquid BandageKMF · Traditional Chesson Laboratory Associates, Inc.07/31/2009SE

More from Chesson Laboratory Associates, Inc.

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Questions and answers

When was TearRepair Liquid Skin Protectant cleared by the FDA?

TearRepair Liquid Skin Protectant (K241916) received a 510(k) decision of Substantially Equivalent on September 27, 2024, 88 days after the submission was received.

What is the product code of K241916?

The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.