clear58
Basic Information
- Brand Name
- clear58
- Primary DI
- 08887861972699
- Version / Model
- clear58
- Company Name
- CLEARLAB SG PTE. LTD.
- Labeler DUNS
- 595115032
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-11
- Public Version
- 1
- Public Version Date
- 2025-08-19
- Public Version Status
- New
- Public Device Record Key
- fe0421dc-9885-40d5-8126-8e1e15a7414d
- Distribution End Date
- 2999-12-31
Device Description
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).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | 886.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47842 | Soft corrective contact lens, daily-wear | A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08887861972699 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030167 | 000 |