Vision Care/Phakosystems Echopach

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

510(k) Number

K880081 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Phakosystems Model 1000/Omni Packs Irrigation/Aspiration

  Class I

  FDA 510(k) K830871 Active Cleared 2 Jun 1983

• Vision Care/Phakosystems Echorule

  Class II

  FDA 510(k) K871938 Active Cleared 23 Nov 1987

• Phakosystems Model Ces 4100

  Class II

  FDA 510(k) K851674 Active Cleared 5 Aug 1985

• Phakosystems CT-100 Cautery Module

  Class II

  FDA 510(k) K860236 Active Cleared 19 Feb 1986

• What is the Vision Care/Phakosystems Echopach used for?

  The Vision Care/Phakosystems Echopach is an ophthalmic ultrasound device used to measure ocular structures, specifically corneal thickness and anterior chamber depth. It provides quantitative diagnostic measurements using ultrasound technology in clinical eye care settings.

• Is the Vision Care/Phakosystems Echopach sterile or single-use?

  The device is not designated as sterile or single-use. It is supplied as a reusable instrument intended for repeated use in clinical settings such as ophthalmology offices or eye clinics, requiring proper cleaning and disinfection between each patient use.

• How is the Vision Care/Phakosystems Echopach supplied and maintained?

  The Vision Care/Phakosystems Echopach is supplied as a reusable ophthalmic ultrasound instrument. It must be cleaned and disinfected between uses according to standard clinical protocols to ensure safe operation in ophthalmology or eye clinic environments.

• What regulatory pathway was used for the Vision Care/Phakosystems Echopach?

  The device received traditional 510(k) clearance from the FDA under submission number K880081. It was determined to be substantially equivalent to a predicate device, with product code IYO and review under the Radiology advisory committee.