clear55A

GUDID 08887861972712

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.

CLEARLAB SG PTE. LTD.

Soft corrective contact lens, daily-wear

• Primary Device ID: 08887861972712
• NIH Device Record Key: 2a356a85-ed37-4ecc-bcdd-f1b1ccf47e42
• Commercial Distribution Discontinuation: 2999-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: clear55A
• Version Model Number: clear55A
• Company DUNS: 595115032
• Company Name: CLEARLAB SG PTE. LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08887861972712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003833

FDA Product Code

• LPL: Lenses, Soft Contact, Daily Wear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-19
• Device Publish Date: 2025-08-11

Devices Manufactured by CLEARLAB SG PTE. LTD.

• 08887861972606 - clear1-day: 2025-08-19 The clear1-day (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophili
• 08887861972613 - clear1-day Toric: 2025-08-19 The clear1-day Toric (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision toric lens. The hydrophi
• 08887861972620 - clear1-day Multifocal: 2025-08-19 The clear1-day Multifocal (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision multifocal lens. Th
• 08887861972675 - clearall-day: 2025-08-19 The clearall-day (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity
• 08887861972682 - clearall-day Toric: 2025-08-19 The clearall-day Toric (hioxifilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in a
• 08887861972699 - clear58: 2025-08-19 The clear58 (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens. The hydrophilic nature
• 08887861972712 - clear55A: 2025-08-19The 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.
• 08887861972712 - clear55A: 2025-08-19 The clear55A Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of
• 08887861972729 - clear55AUV: 2025-08-19 The clear55AUV Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion