CLARO

Over-the-counter Powered Light Based Laser For Acne

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: K090744
• 510k Number: K090744
• Device Name: CLARO
• Classification: Over-the-counter Powered Light Based Laser For Acne
• 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: OLP
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-20
• Decision Date: 2010-04-15
• Summary: summary