clear58

FDA UDI

Class II (US FDA UDI)

by Clearlab Sg Pte. Ltd.

Identity

Trade Name: clear58 FDA UDI
Generic Name: Soft corrective contact lens, daily-wear FDA UDI
Device Name: 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). FDA UDI
Model / Reference: clear58 FDA UDI
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). FDA UDI

Identifiers

Primary DI / UDI-DI: 08887861972699 FDA UDI
510(k) Number: K030167 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

clear58 by Clearlab Sg Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 fe0421dc-9885-40d5-8126-8e1e15a7414d 35 fields · synced Jun 1, 2026