Bright

Light Based Over The Counter Wrinkle Reduction

Tanda Beauty Canada Inc.

The following data is part of a premarket notification filed by Tanda Beauty Canada Inc. with the FDA for Bright.

Pre-market Notification Details

• Device ID: K161849
• 510k Number: K161849
• Device Name: Bright
• Classification: Light Based Over The Counter Wrinkle Reduction
• Applicant: Tanda Beauty Canada Inc. 11-380 Jamieson Parkway Cambridge, CA
• Contact: Bobae Kim
• Correspondent: Janice M. Hogan; Hogan Lovells US LLP 1835 Market St., 29th Floor Philadelphia, PA 19103
• Product Code: OHS
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-07-05
• Decision Date: 2016-07-29
• Summary: summary