ADVATX

Powered Laser Surgical Instrument

ADVALIGHT APS

The following data is part of a premarket notification filed by Advalight Aps with the FDA for Advatx.

Pre-market Notification Details

• Device ID: K132976
• 510k Number: K132976
• Device Name: ADVATX
• Classification: Powered Laser Surgical Instrument
• Applicant: ADVALIGHT APS 5 TIMBER LANE North Reading, MA 01864
• Contact: Maureen O'connell
• Correspondent: Maureen O'connell; ADVALIGHT APS 5 TIMBER LANE North Reading, MA 01864
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-23
• Decision Date: 2014-04-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05700002052209	K132976	000