clear58

GUDID 08887861972699

The clear58 (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The ionic lens material, (etafilcon A) is a co-polymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1 ,l ,l - trimethylol propane trimethacrylate and ethylene glycol demethacrylate. It consists of 42% etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 2 1 CFR part 73.3 12 1. The (etafilcon A) name has been adopted by the United States Adopted Names Council (USAN).

CLEARLAB SG PTE. LTD.

Soft corrective contact lens, daily-wear

• Primary Device ID: 08887861972699
• NIH Device Record Key: fe0421dc-9885-40d5-8126-8e1e15a7414d
• Commercial Distribution Discontinuation: 2999-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: clear58
• Version Model Number: clear58
• 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	08887861972699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030167

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: 2025-08-19The clear58 (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The ionic lens material, (etafilcon A) is a co-polymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1 ,l ,l - trimethylol propane trimethacrylate and ethylene glycol demethacrylate. It consists of 42% etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 2 1 CFR part 73.3 12 1. The (etafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
• 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: 2025-08-19 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