clear55A

FDA UDI

Class II (US FDA UDI)

by Clearlab Sg Pte. Ltd.

Identity

Trade Name: clear55A FDA UDI
Generic Name: Soft corrective contact lens, daily-wear FDA UDI
Device Name: The clear55A Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The clear55A Contact Lens is available in a single vision lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55%). All lenses are tinted using the color additive Reactive Blue #19. The clear55A (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity. FDA UDI
Model / Reference: clear55A FDA UDI
Description: The clear55A Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The clear55A Contact Lens is available in a single vision lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55%). All lenses are tinted using the color additive Reactive Blue #19. The clear55A (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity. FDA UDI

Identifiers

Primary DI / UDI-DI: 08887861972712 FDA UDI
510(k) Number: K003833 FDA UDI
FDA Product Code: LPL FDA UDI
GMDN Term: Soft corrective contact lens, daily-wear FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.5925 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Soft corrective contact lens, daily-wear

clear55A by Clearlab Sg Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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HAPA KRISTIN — INTEROJO INC. · Class II
Loox — Camden Passage Inc · Class II
ArtMost SoftOK Daily Wear Soft Contact Lens — SEINOH OPTICAL CO., LTD. · Class II
ArtMost SoftOK Daily Wear Soft Contact Lens — SEINOH OPTICAL CO., LTD. · Class II

Cleared under the same submission

K003833 also covers:

clear55AUV — CLEARLAB SG PTE. LTD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Clearlab Sg Pte. Ltd.

Sources (1)

FDA UDI 2a356a85-ed37-4ecc-bcdd-f1b1ccf47e42 35 fields · synced Jun 6, 2026