Rosso

Powered Laser Surgical Instrument

Quanta System SpA

The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Rosso.

Pre-market Notification Details

• Device ID: K211228
• 510k Number: K211228
• Device Name: Rosso
• Classification: Powered Laser Surgical Instrument
• Applicant: Quanta System SpA Via Acquedotto 109 Samarate, IT Varese
• Contact: Francesco Dell'antonio
• Correspondent: Dario Bandiera; Quanta System SpA Via Acquedotto 109 Samarate, IT Varese
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-23
• Decision Date: 2022-02-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08059173396405	K211228	000
08059173396399	K211228	000