# K030167: Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Clearlab Pte, Ltd.
- Decided: Apr 2, 2003 after 76 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962804 (1996). 4 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020855: Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,Igel 55 UV Multifocal (Methafilcon a) Soft, Igel Vision Care Pte, Ltd. (2002) Summary page 2.
- K980634: Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted), Aspect Vision Care, Ltd. (1998) Summary page 2.
- K962804: Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker, Vistakon, Johnson & Johnson Vision Products, Inc. (1996) Summary page 2.

## Most influential descendants
- K052290: Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens (2006), 5 descendants of its own
- K080632: CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens (2008), 3 descendants of its own
- K102895: One Day Flat Pack (2011), 1 descendant of its own
- K192129: ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens (2019), 0 descendants of its own
- K180819: One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens (2018), 0 descendants of its own

## Indications for use
The MIERU (etafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The MIERU (etafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D or less. The MIERU (etafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K030167
Methodology: https://510kreport.com/methodology