Nexy

Camera, Ophthalmic, Ac-powered

Next Sight Srl

The following data is part of a premarket notification filed by Next Sight Srl with the FDA for Nexy.

Pre-market Notification Details

• Device ID: K180306
• 510k Number: K180306
• Device Name: Nexy
• Classification: Camera, Ophthalmic, Ac-powered
• Applicant: Next Sight Srl Via IV Novembre 6/E Limena, IT 35010
• Contact: Arianna Dalla Ba
• Correspondent: Arianna Dalla Ba; Next Sight Srl Via IV Novembre 6/E Limena, IT 35010
• Product Code: HKI
• CFR Regulation Number: 886.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-02
• Decision Date: 2018-06-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B667NEXY01	K180306	000
03615020000465	K180306	000