RTA Retinal Thickness Analyzer Modification

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

Full name

Modification to Rta Retinal Thickness Analyzer

510(k) Number

K000731 ↗

FDA Product Code

HLI

FDA applicant

Talia Technology , Ltd.

Device Class

Class II

Regulation

21 CFR Part 886.1570

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• RTA Retinal Thickness Analyzer

  Class II

  FDA 510(k) K964137 Active Cleared 3 Feb 1997

• Rta 5 & Rta Model E Retinal Thickness Analyzer

  Class II

  FDA 510(k) K061674 Active Cleared 23 Aug 2006

• Rta Model D Retinal Thickness Analyzer

  Class II

  FDA 510(k) K041290 Active Cleared 24 May 2004

• Talia Laser Slit

  Class II

  FDA 510(k) K930518 Active Cleared 25 Jan 1994

• RTA Model D Retinal Thickness Analyzer

  Class II

  FDA 510(k) K031312 Active Cleared 6 May 2003

• Is this device single-use or reusable, and what maintenance is required?

  The MODIFICATION TO RTA RETINAL THICKNESS ANALYZER is designed as a reusable instrument and requires proper calibration and maintenance to ensure accurate retinal imaging and ocular media assessment. Since it is classified as a reusable Class II device under FDA regulations, adherence to manufacturer guidelines for cleaning, sterilization (if applicable), and periodic servicing is essential for reliable performance and compliance with regulatory standards.

• What types of ocular structures can this device analyze, and how does it work?

  This device uses illumination and optical systems to assess retinal thickness and examine multiple ocular media, including the cornea, aqueous, lens, and vitreous. It performs in vivo retinal analysis, allowing clinicians to evaluate structural details of the eye without invasive procedures. The technology relies on precise imaging to support diagnostic decisions in clinical ophthalmology.

• How is this device regulated, and what does the FDA clearance cover?

  The MODIFICATION TO RTA RETINAL THICKNESS ANALYZER holds an FDA 510(k) clearance (K000731) under the Special 510(k) Review Program, classified as Substantially Equivalent to predicate devices. This clearance confirms compliance with FDA standards for ophthalmic diagnostic equipment, specifically for modifications to existing retinal thickness analyzers. The regulatory route ensures the device meets safety and performance requirements for clinical ophthalmology use.

• Is this device AC-powered, and what clinical settings is it intended for?

  Yes, the device is AC-powered and is intended for use in clinical ophthalmology settings. It is designed for professional use in environments where retinal imaging and ocular media assessment are performed, such as hospitals, eye clinics, or specialized ophthalmology practices. The modification ensures compatibility with existing RTA systems while maintaining regulatory compliance.