IRestore

Laser, Comb, Hair

Freedom Laser Therapy, Inc.

The following data is part of a premarket notification filed by Freedom Laser Therapy, Inc. with the FDA for Irestore.

Pre-market Notification Details

• Device ID: K151662
• 510k Number: K151662
• Device Name: IRestore
• Classification: Laser, Comb, Hair
• Applicant: Freedom Laser Therapy, Inc. 7815 Beverly Blvd., 3rd Floor Los Angeles, CA 90036
• Contact: Craig Nabat
• Correspondent: Raymond R. Blanche; NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, NJ 07928
• Product Code: OAP
• CFR Regulation Number: 890.5500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-06-19
• Decision Date: 2016-01-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859690003361	K151662	000