FDA 510(k)

TearRepair Liquid Skin Protectant

K-Number: K241916 · 2024-09-27

Decision Date2024-09-27

Product CodeKMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TearRepair Liquid Skin Protectant is the device name listed in this FDA 510(k) record. The listed applicant is Optmed, Inc.. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K241916. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TearRepair Liquid Skin Protectant?

TearRepair Liquid Skin Protectant is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Optmed, Inc.. The 510(k) number is K241916.

When did TearRepair Liquid Skin Protectant receive FDA 510(k) clearance?

TearRepair Liquid Skin Protectant received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241916.

Who is the listed applicant for TearRepair Liquid Skin Protectant?

The FDA 510(k) record lists Optmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TearRepair Liquid Skin Protectant?

The FDA product code for TearRepair Liquid Skin Protectant is KMF.

Other records listing Optmed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243990BondEase 2 Topical Skin Adhesive

Related Devices (Code: KMF)

K182733Rochal Bioshield Silicone FilmRochal Industries, LLC K171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.