Question 1

What type of medical devices does ClearLab SG Pte. Ltd. manufacture?

Accepted Answer

ClearLab SG Pte. Ltd. manufactures soft corrective contact lenses designed for daily wear and daily disposable use, including multifocal, toric, and colored variants made from materials such as hioxifilcon A, which are intended to correct vision.

Question 2

Where is ClearLab SG Pte. Ltd. based?

Accepted Answer

ClearLab SG Pte. Ltd. is based in the United States, as indicated in the company's country of registration within the provided device data.

Question 3

In which regulatory registries are ClearLab SG Pte. Ltd.'s devices listed?

Accepted Answer

The devices manufactured by ClearLab SG Pte. Ltd. are listed in the FDA’s 510(k) and UDI registries, which are used to track medical device submissions and unique device identifiers for traceability and oversight.

Question 4

How are ClearLab SG Pte. Ltd.'s contact lenses classified as medical devices?

Accepted Answer

ClearLab SG Pte. Ltd.'s soft corrective contact lenses are classified as Class II medical devices, indicating they require special controls to ensure safety and effectiveness, but do not undergo the most stringent premarket approval process.

Device	Model / Reference	Registries	Class	Status
clear1-day Multifocal	clear1-day Multifocal	FDA UDI	Class II	Active
clearall-day	clearall-day	FDA UDI	Class II	Active
clear55A	clear55A	FDA UDI	Class II	Active
clearall-day Toric	clearall-day Toric	FDA UDI	Class II	Active
clear55AUV	clear55AUV	FDA UDI	Class II	Active
clear1-day	clear1-day	FDA UDI	Class II	Active
clear1-day Toric	clear1-day Toric	FDA UDI	Class II	Active
clear58	clear58	FDA UDI	Class II	Active
Aquasoft All-Day & All-Day T (hioxifilcon A) Daily Wear Contact Lens	K052290	FDA 510(k)	Class II	Active
Aquasoft (ocufilcon D) Daily Wear Contact Lens Clear And Visibility Tint, With Uv Blocker	K030748	FDA 510(k)	Class II	Active
Specialty 55 & Multifocal (methafilcon A) Soft (hydrophilic Contact Lenses For Daily Wear	K003833	FDA 510(k)	Class II	Active
Mieru (etafilcon A) Daily Wear Contact Lens Clear And Visibility Tint, With Uv Blocker	K030167	FDA 510(k)	Class II	Active
ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens	K192129	FDA 510(k)	Class II	Active
Clear1-Day Hioxifilcon Daily Disposable Soft Contact Lens	K080632	FDA 510(k)	Class II	Active

CLEARLAB SG PTE. LTD.

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