Mieru (Etafilcon A) Daily Wear Contact Lens Clear and Visibility Tint with UV Blocker
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030167 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)
The Mieru (etafilcon A) is a spherical soft contact lens for daily wear, indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes affected by myopia or hyperopia. The lens is made of etafilcon A copolymer (42% polymer, 58% water) and contains a UV-absorbing benzophenone monomer to help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lens is available with an optional Reactive Blue 19 visibility tint and is supplied as a single-use device. It is classified as a Class II medical device with FDA 510(k) clearance (K030167) under product code LPL, regulation number 886.5925, and is manufactured by Clearlab Pte Ltd.
Frequently asked questions
What is the Mieru contact lens used for?
The Mieru contact lens is a spherical soft contact lens designed for daily wear to correct visual acuity in aphakic and non-aphakic persons with non-diseased eyes affected by myopia or hyperopia.
Is the Mieru contact lens reusable or single-use?
The Mieru contact lens is supplied as a single-use device, meaning it should be discarded after each use and not reused for multiple days of wear.
What materials are used in the Mieru contact lens?
The Mieru lens is made of etafilcon A copolymer containing 42% polymer and 58% water, with an added UV-absorbing benzophenone monomer to help protect against harmful UV radiation transmission to the cornea and into the eye.
What options are available for the Mieru contact lens?
The Mieru contact lens is available in both clear and with an optional Reactive Blue 19 visibility tint, allowing users to choose based on their preference for lens visibility during insertion and removal.
What is the regulatory classification of the Mieru contact lens?
The Mieru contact lens is classified as a Class II medical device with FDA 510(k) clearance (K030167) under product code LPL and regulation number 886.5925, manufactured by Clearlab Pte Ltd.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mieru (Etafilcon A) Daily Wear Contact Lens Clear and Visibility Tint ..., Mieru (etafilcon A) Daily Wear Contact Lens Clear And Visibility Tint ..., PDF Clearlab SG Pte Ltd, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030167 | Class II | Active |
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Manufacturer
- Manufacturer
- Clearlab Pte , Ltd.
Sources (1)
- FDA 510(k) K030167 24 fields · synced Oct 6, 2026