ETHEREA

Powered Laser Surgical Instrument

REGULATORY INSIGHT, INC.

The following data is part of a premarket notification filed by Regulatory Insight, Inc. with the FDA for Etherea.

Pre-market Notification Details

• Device ID: K112505
• 510k Number: K112505
• Device Name: ETHEREA
• Classification: Powered Laser Surgical Instrument
• Applicant: REGULATORY INSIGHT, INC. 5401 S.COTTONWOOD COURT Greenwood Village, CO 80121
• Contact: Kevin Walls
• Correspondent: Kevin Walls; REGULATORY INSIGHT, INC. 5401 S.COTTONWOOD COURT Greenwood Village, CO 80121
• Product Code: GEX
• Subsequent Product Code: ILY
• Subsequent Product Code: ONF
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-08-30
• Decision Date: 2012-04-06