Home / 510(k) Clearances / DEN200063

510(k) DEN200063

Kerasave by Al.Chi.Mi.A. S.R.L — Product Code QCW

DEN200063 is an FDA 510(k) premarket notification submitted by Al.Chi.Mi.A. S.R.L for the device "Kerasave". The FDA issued a decision of De Novo Granted on May 2, 2022. The device falls under product code QCW (Corneal Storage Media With Preservatives Including Anti-Fungal), a Class II device regulated under 21 CFR 886.4320. Al.Chi.Mi.A. S.R.L has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 2, 2022
Date Received
October 1, 2020
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Corneal Storage Media With Preservatives Including Anti-Fungal
Device Class
Class II
Regulation Number
886.4320
Review Panel
OP
Submission Type

Media to preserve human corneas while in storage.

Other clearances by Al.Chi.Mi.A. S.R.L

  • K251320 — XTRA4 (September 11, 2025)
  • K162013 — Eusol-C (September 15, 2016)
  • K063617 — EUSOL-C (February 8, 2007)
  • K032422 — EUSOL-C (December 15, 2003)

FDA data resources