OCUSYSTEM ART ADVANTAGE, MODEL 995

• K Number: K991852
• Device Name: OCUSYSTEM ART ADVANTAGE, MODEL 995
• Manufacturer: SURGICAL DESIGN CORP.
• Date Cleared: 1999-07-07 ( 36 days)
• Product Code: HQC
• Regulation Number: 886.4670
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

Phacoemulsification of cataracts in the human eye.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "Ocusystem Art Advantage®" for phacoemulsification of cataracts. It confirms the device's substantial equivalence to a predicate device and permits its marketing.

However, the document does not describe the acceptance criteria or any study details regarding device performance. It mainly focuses on regulatory aspects and does not include scientific or clinical study data.

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.