LYFT

Over-the-counter Powered Light Based Laser For Acne

Uplevity, Inc.

The following data is part of a premarket notification filed by Uplevity, Inc. with the FDA for Lyft.

Pre-market Notification Details

• Device ID: K180888
• 510k Number: K180888
• Device Name: LYFT
• Classification: Over-the-counter Powered Light Based Laser For Acne
• Applicant: Uplevity, Inc. 40 Marshfield Rd Niantic, CT 06357
• Contact: Thomas Kraft
• Correspondent: Marc C. Sanchez; Contract In-House Counsel And Consultants, LLC (d/b/a FDA Atty) 1717 Pennsylvania Ave., Ste. 1025 Washington, DC 27517
• Product Code: OLP
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-04
• Decision Date: 2018-08-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00855950007049	K180888	000