MYAH

Device, Analysis, Anterior Segment

VISIA Imaging S.R.L.

The following data is part of a premarket notification filed by Visia Imaging S.r.l. with the FDA for Myah.

Pre-market Notification Details

• Device ID: K211868
• 510k Number: K211868
• Device Name: MYAH
• Classification: Device, Analysis, Anterior Segment
• Applicant: VISIA Imaging S.R.L. Via Martiri Della Libertà, 95/e San Giovanni Valdarno, IT 52027
• Contact: Alessia Magnanini
• Correspondent: Marisa Testa; Thema S.R.L. Via Saragat 5 Imola, IT 40026
• Product Code: MXK
• CFR Regulation Number: 886.1850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-16
• Decision Date: 2022-03-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08034028770456	K211868	000
08034028770463	K211868	000