Unicon (etafilcon A) Soft (hydrophilic) Contact Lens With Uv Blocker For Daily …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141917

Identifiers

510(k) Number: K141917 FDA 510(k)
FDA Product Code: LPL FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 886.5925 FDA 510(k)
Regulation Number: 886.5925 FDA 510(k)
Advisory Committee: Ophthalmic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Unicon (etafilcon A) Soft (hydrophilic) Contact Lens With Uv Blocker For Daily … by Unicon Optical Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K141917	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Unicon Optical Co., Ltd.

Sources (1)

FDA 510(k) K141917 24 fields · synced Jun 18, 2026