FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The bifocal/multifocal designs of the HYDRO2 (filofocon A) contact lens are indicated for daily wear correction of visual acuity in non-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic. The lens may be disinfected with chemical disinfection only.

Device Description

Bifocal/Multifocal HYDRO2 (filofocon A) Daily Wear RGP Contact Lens

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a contact lens, not a study report or a document describing acceptance criteria and device performance. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, ground truth, or expert qualifications.

The document states that the FDA reviewed a "Section 510(k) notification of intent to market the device" and found it to be "substantially equivalent" to a legally marketed predicate device. This process involves comparing the new device to an existing one, but the specific performance data and criteria used for that comparison are not detailed in this clearance letter.

Therefore, I cannot extract the requested information from the provided text.

Ask a Question

Ask a specific question about this device

K Number

K000485

Device Name

HYDRO2, HS-75

Manufacturer

INNOVISION, INC.

Date Cleared

2000-05-12

(88 days)