Chrome

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 Chrome.

Pre-market Notification Details

• Device ID: K202503
• 510k Number: K202503
• Device Name: Chrome
• Classification: Powered Laser Surgical Instrument
• Applicant: Quanta System Spa via Acquedotto, 109 Samarate (va), IT 21017
• Contact: Francesco Dell'antonio
• Correspondent: Francesco Dell'antonio; Quanta System Spa via Acquedotto, 109 Samarate (va), IT 21017
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-08-31
• Decision Date: 2020-11-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08059173391813	K202503	000
08059173391806	K202503	000