VS3-IR System

Confocal Optical Imaging

VISIONSENSE LTD

The following data is part of a premarket notification filed by Visionsense Ltd with the FDA for Vs3-ir System.

Pre-market Notification Details

• Device ID: K152204
• 510k Number: K152204
• Device Name: VS3-IR System
• Classification: Confocal Optical Imaging
• Applicant: VISIONSENSE LTD 20 HAMAGSHIMIM ST Petach Tikva, Hamerkaz, IL 49348
• Contact: Alex Chanin
• Correspondent: Raymond Kelly; LICENSALE INC 57 LAZY BROOK RD Monroe, CT 06468
• Product Code: OWN
• Subsequent Product Code: GCJ
• Subsequent Product Code: GWG
• Subsequent Product Code: HRX
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2015-08-06
• Decision Date: 2015-10-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10813040013704	K152204	000
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