clear1-day

GUDID 08887861972606

The clear1-day (hioxifilcon A) Daily Disposable Soft 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 non-ionic lens material, (hioxifilcon A) is a ultra high molecular weight random copolymer of 2- hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxpropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifilcon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility- handling tint, color additive 'Reactive Blue # 4', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

CLEARLAB SG PTE. LTD.

Soft corrective contact lens, daily-disposable
Primary Device ID08887861972606
NIH Device Record Key4ab3a5f4-c9f5-4d5e-9467-2651c58e573b
Commercial Distribution Discontinuation2999-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand Nameclear1-day
Version Model Numberclear1-day
Company DUNS595115032
Company NameCLEARLAB SG PTE. LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108887861972606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPLLenses, Soft Contact, Daily Wear

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-19
Device Publish Date2025-08-11

Devices Manufactured by CLEARLAB SG PTE. LTD.

08887861972606 - clear1-day2025-08-19The clear1-day (hioxifilcon A) Daily Disposable Soft 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 non-ionic lens material, (hioxifilcon A) is a ultra high molecular weight random copolymer of 2- hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxpropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifilcon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility- handling tint, color additive 'Reactive Blue # 4', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
08887861972606 - clear1-day2025-08-19 The clear1-day (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophili
08887861972613 - clear1-day Toric2025-08-19 The clear1-day Toric (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision toric lens. The hydrophi
08887861972620 - clear1-day Multifocal2025-08-19 The clear1-day Multifocal (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision multifocal lens. Th
08887861972675 - clearall-day2025-08-19 The clearall-day (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity
08887861972682 - clearall-day Toric2025-08-19 The clearall-day Toric (hioxifilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in a
08887861972699 - clear582025-08-19 The clear58 (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens. The hydrophilic nature
08887861972712 - clear55A2025-08-19 The clear55A Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of
08887861972729 - clear55AUV2025-08-19 The clear55AUV Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion

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