COOLTOUCH

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

NEW STAR LASERS, INC.

The following data is part of a premarket notification filed by New Star Lasers, Inc. with the FDA for Cooltouch.

Pre-market Notification Details

• Device ID: K103338
• 510k Number: K103338
• Device Name: COOLTOUCH
• Classification: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
• Applicant: NEW STAR LASERS, INC. 9085 FOOTHILLS BLVD. Roseville, CA 95747
• Contact: Natalie R Vollrath
• Correspondent: Natalie R Vollrath; NEW STAR LASERS, INC. 9085 FOOTHILLS BLVD. Roseville, CA 95747
• Product Code: PDZ
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-15
• Decision Date: 2011-11-01
• Summary: summary