SilSoft (Elastofilcon A) Contact Lens

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Lenses, soft contact, daily wear

PMA Number

P800020 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

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• What is the SilSoft (Elastofilcon A) Contact Lens primarily used for in clinical practice?

  The SilSoft (Elastofilcon A) Contact Lens is designed for daily wear and is specifically intended to correct vision for patients who have undergone cataract surgery without intraocular lens implantation, a condition known as aphakia. It is not intended for other types of vision correction or medical conditions.

• How is the SilSoft (Elastofilcon A) Contact Lens supplied, and is it single-use?

  The SilSoft (Elastofilcon A) Contact Lens is supplied in single-use vials, meaning each vial contains one lens intended for one-time use only. This design helps ensure hygiene and reduces the risk of contamination.

• What regulatory pathway was followed for the approval of the SilSoft (Elastofilcon A) Contact Lens?

  The SilSoft (Elastofilcon A) Contact Lens was approved through the FDA’s Premarket Approval (PMA) process, which is a rigorous regulatory pathway for high-risk medical devices. The approval number assigned is P800020, and it is classified as a Class II medical device under FDA regulations.

• Are there different sizes or models available for the SilSoft (Elastofilcon A) Contact Lens?

  The provided data does not specify individual sizes or models beyond the generic classification of 'Lenses, soft contact, daily wear.' However, the registration numbers and product codes (e.g., LPL) suggest multiple variants may exist, likely tailored to different prescription needs or patient anatomies. For exact sizes or models, refer to the manufacturer’s documentation or catalog.