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510(k) Data Aggregation

K Number

DEN200063

Device Name

Kerasave

Manufacturer

AL.CHI.MI.A. S.r.l

Date Cleared

2022-05-02

(578 days)

Product Code

QCW

Regulation Number

886.4320

Intended Use

Kerasave is indicated for storage of human corneas at 2-8°C for up to 14 days. It is intended for prescription (Rx) use by physicians or highly skilled personnel, such as Eye Bank operators.

Device Description

Kerasave is made of a buffered corneal storage medium, which provides basic nutrients for cell maintenance during storage of donor corneas at 2-8°C for up to 14 days, at physiological pH. The device also includes antimicrobial agents. The antibiotics are dissolved in the solution and an antifungal agent is formulated as a tablet for stability reason and constitutes integral part of the device; it shall be dissolved in the medium prior to use.

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K Number

K162013

Device Name

Eusol-C

Manufacturer

AL.CHI.MI.A. S.r.l.

Date Cleared

2016-09-15

(56 days)

Product Code

LYX

Regulation Number

N/A

Intended Use

Eusol-C is indicated when it is desired to store explanted corneas for up to 14 days. It is intended for use by physicians or highly skilled personnel, such as Eye Bank operators.

Device Description

Not Found

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