CLARO

Powered Laser Surgical Instrument

CLRS TECHNOLOGY CORPORATION

The following data is part of a premarket notification filed by Clrs Technology Corporation with the FDA for Claro.

Pre-market Notification Details

• Device ID: K080638
• 510k Number: K080638
• Device Name: CLARO
• Classification: Powered Laser Surgical Instrument
• Applicant: CLRS TECHNOLOGY CORPORATION 5 TIMBER LANE North Reading, MA 01864
• Contact: Maureen O'connell
• Correspondent: Maureen O'connell; CLRS TECHNOLOGY CORPORATION 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: 2008-03-06
• Decision Date: 2008-09-17
• Summary: summary