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510(k) K241916

TearRepair Liquid Skin Protectant by Optmed, Inc. — Product Code KMF

K241916 is an FDA 510(k) premarket notification submitted by Optmed, Inc. for the device "TearRepair Liquid Skin Protectant". The FDA issued a decision of Substantially Equivalent on September 27, 2024. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Optmed, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2024
Date Received
July 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Optmed, Inc.

  • K243990 — BondEase 2 Topical Skin Adhesive (September 19, 2025)
  • K141157 — BONDEASE TOPICAL SKIN ADHESIVE (December 22, 2015)

Other clearances for product code KMF

  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)
  • K083913 — CHESSON LABS LIQUID BANDAGE (July 31, 2009)

FDA data resources